TOP: Trial of the Effect of Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00172081
First received: September 9, 2005
Last updated: January 20, 2009
Last verified: September 2005
  Purpose

This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH [1-84]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.


Condition Intervention Phase
Osteoporosis
Drug: ALX1-11
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An 18-Month Double-Blind, Placebo-Controlled, Phase III, Trial With a 12-Month Interim Analysis of the Effect of Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:
  • Compare effects of 18 months of treatment with ALX1-11/placebo on the incidence of new and/or worsened thoracic and lumbar vertebral fractures in postmenopausal women with osteoporosis receiving calcium and vitamin D3 supplements

Secondary Outcome Measures:
  • To evaluate the safety of ALX1-11 and to compare the effects of ALX1-11 or placebo treatment on additional measures of efficacy

Estimated Enrollment: 2600
Study Start Date: April 2000
Estimated Study Completion Date: November 2003
Detailed Description:

Parathyroid hormone (PTH), a polypeptide consisting of 84 amino acids that is synthesized and secreted by the parathyroid glands, is a principal regulator of calcium homeostasis through concerted action on kidney, intestine and bone. Parathyroid hormone exerts its action on bone to release calcium into the extracellular fluid as a process of bone remodeling and also to maintain the serum calcium concentration, but the exact mechanisms are not fully understood. In some circumstances, PTH may exert an anabolic action on bone and can stimulate osteoblast proliferation and mature osteoblast function. The net effect of exogenous PTH administration on bone turnover depends on the pattern of delivery. A continuous long-term infusion gives a net decrease in trabecular bone volume, whereas daily single injections result in a net increase.

NPS Allelix Corp. is developing ALX1-11, recombinant human parathyroid hormone (1-84), for the treatment of osteoporosis. ALX1-11 is identical to the endogenous intact 84 amino acid human hormone and will be self-administered on a daily basis by subcutaneous (sc) injection.

Currently, there is no approved therapy for osteoporosis capable of stimulating the formation of new bone of normal composition and structure. Most therapies in development are anti-catabolic and only prevent further bone loss (e.g., estrogen replacement, bisphosphonates, and calcitonins). ALX1-11 has the potential to stimulate new bone formation in osteoporotic patients, thereby increasing bone mass and preventing fractures. Patients with moderately or severely reduced bone density and a fracture would be expected to benefit from treatment, thereby improving functional status and alleviating symptoms.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who are postmenopausal with at least one year since the last menstruation. If a patient's menopausal status at screening is in question, by history or due to the patient having a hysterectomy without oophorectomy, a follicle-stimulating hormone (FSH) level can be obtained after discussion with the Project Medical Officer (PMO). Patients with an FSH > 40 mIU/mL will satisfy the definition of postmenopausal status.
  • Women who are 45-54 years of age with the following bone mineral density (BMD) and/or vertebral fracture:

    • BMD 3.0 standard deviations (SDs) or more below peak bone mass of young females at the lumbar spine, femoral neck, or total hip; or
    • BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
  • Women 55 or more years of age with the following BMD and/or vertebral fracture:

    • BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip; or
    • BMD 2.0 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
  • The following types of vertebral fractures should not be considered for patient enrollment into this trial:

    • Pathological fractures due to malignant disease or infection
    • Fractures due to excessive trauma sufficient to cause a fracture in young individuals with normal bone mass
  • Women with the ability to self-administer a daily injection or have a designee who will give the injections
  • Women who are capable of understanding and giving written, voluntary informed consent before the clinical trial screening visit

Exclusion Criteria:

A. Vertebral Deformity:

  • Patient has 5 or more vertebral (thoracic and lumbar) deformities
  • Patient has 2 or more lumbar vertebral deformities (L1 to L4)
  • Severe lumbar scoliosis (>15 degrees) which precludes a reliable evaluation of the dual x-ray absorptiometry (DXA)

B. DXA Imaging:

  • Inability to have a DXA scan performed, e.g.:

    • A history of a lumbar laminectomy which interferes with the DXA measurement of the lumbar vertebrae
    • The presence of pedicle screws
    • The patient cannot lay flat on her back for the required time to provide accurate imaging
    • Patient is not able to have an A/P lumbar vertebral DXA performed
    • Patient has a history of vertebroplasty
    • Any other excessive degenerative disease which interferes with the DXA measurement of the lumbar vertebrae or hip.

C. History or Concurrent Illness:

  • Disorders of immunity:

    • HIV
    • Significant immunological disorders
    • Possible allergies to the product (ALX 1-11) or its constituents
  • Endocrine system:

    • Any history of hyper- or hypoparathyroidism
    • Cushing's disease
    • Hyperthyroidism (within 12 months prior to the screening visit)
    • Significant endocrine disorders
  • Gastrointestinal system:

    * Significant gastrointestinal disorders

  • Kidney and collecting system:

    • Clinically important history of nephrolithiasis or urolithiasis
    • Current impaired renal function and/or verified kidney calcification
    • Significant renal disorders
  • Liver, biliary tract and pancreatic systems:

    • Active hepatitis or pancreatitis
    • Significant hepatic or pancreatic disorders
  • Musculoskeletal system:

    * Any history of other metabolic bone diseases within the past 5 years, e.g., Paget´s disease, osteogenesis imperfecta, osteomalacia

  • Neoplasia:

    • Any history of bone cancer
    • Any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma. Patients who have had either squamous or basal cell carcinoma of the skin may enter the screening visits for this study if:

      1. the lesion(s) were fully resected with clear margins described in a written report by a pathologist; and
      2. the patient has had no recurrence of lesions for at least one year from the time of the original resection.
  • Nervous system:

    * Significant neurological or psychiatric disease

  • Vascular, respiratory and cardiac system:

    * Significant unstable cardiac or pulmonary disease

  • Significant diseases or disorders are determined by history, physical exam or laboratory screens and judged by the Principal Investigator to be significant.

D. Concurrent Medication:

Any patient who does not require medication washout (discontinuation) as specified below may start study drug dosing after 2 weeks of stabilization treatment with calcium and vitamin D3 supplements. All exceptions will be documented in the case report form (CRF).

  • Patients cannot be enrolled into this clinical trial if they have received any of the following therapies at any time:

    • Any PTH or PTH analogs [e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs]
    • Fluoride
    • Strontium
  • Patients must have been off the following agents for the specified times before entering the screening phase of this clinical trial:

    • Any investigational drug (30 days)
    • Anabolic steroids or androgens (6 consecutive months)
    • Active vitamin D3 metabolites and analogs, e.g., calcitriol (90 days)
    • Systemic corticosteroids, more than 5 mg/day prednisone or a systemic corticosteroid formulation equivalent to 5 mg/day prednisone (12 consecutive months). Steroid use in excess of 5mg/day requires PMO approval and may require consultation with the CAB.
    • A patient who has been enrolled in the study and needs to receive an acute bolus of steroids (oral or injectable) for a self-limited illness may continue treatment in the study if the following requirements are met:

      1. Exposure to steroids is limited to no more than 30 consecutive days
      2. The maximal dose of steroid (prednisone equivalent) is limited to no more than 225 mg (7.5 mg each day for 30 days)
      3. The illness is acute in nature and is not expected to recur during the remaining treatment period of the study
    • Daily inhaled corticosteroids unless dose is below 1200 mg/day of beclomethasone.
    • Bisphosphonates, including investigational bisphosphonates. If the patient has received bisphosphonates for more than 90 days during the 12-month period prior to start of study drug, the patient is excluded from this study. The patient may be enrolled if she: has taken bisphosphonates for greater than or equal to 30 days but less than or equal to 90 days, and completes a washout (i.e., bisphosphonate is discontinued) for an amount of time equivalent to the amount of time that bisphosphonate therapy was received prior to having any screening visit and evaluations performed. No washout is necessary if the patient has taken bisphosphonates for less than 30 days. If the patient has ever received more than 12 months of bisphosphonate therapy, the patient is excluded from this study.
    • Intravenous (IV) pamidronate. Patient must be receiving pamidronate specifically to treat osteoporosis. Patient can have received only ONE IV dose of pamidronate in the 12 months immediately preceding the screening visit. Patient should not have received this one dose within the three months immediately prior to the screening visit. Patient must not have received more than TWO IV doses of pamidronate as treatment at any time.
    • Cyclical etidronate. Exposure to cyclical etidronate must be less than or equal to 6 months on a standard dose (e.g. 400 mg/day). Patient should not have exposure to cyclical etidronate for 9 months prior to the screening visit.
    • Phenytoin for seizure control. If the patient has received phenytoin within five years of the screening visit, the patient is excluded from this study. The patient may continue in the screening process if 15 years have passed since the last dose of phenytoin at the time of the screening visit. If the phenytoin use was between 5-15 years before the screening visit and the patient received phenytoin for less than 2 months.
  • Patients may be enrolled if they have been stabilized on the following therapy for the specified amount of time:

    • Thyroid hormone (<0.1 mg/day thyroxine) therapy for at least 6 months. If taking > 0.1 mg/day but < 0.2 mg/day, must have serum thyroid stimulating hormone (TSH) level > 0.1 mU/L. Patients will be excluded if they are taking doses of > 0.2 mg/day. If a patient has had a minimal change in L-thyroxine dose of less than or equal to 0.025 mg/day within 6 months of the screening visit, and has been on this new dose for at least 2 months, she may continue in the screening process for this clinical study. The patient's history with L-thyroxine must be clearly documented in the source documents. If a patient requires an increase in her thyroid replacement dose, after she has been enrolled in this clinical study, each increment should be less than or equal to 0.025mg/day, and increments should not occur more frequently than once per month, as recommended by a physician who is caring for the patient. The patient must have a TSH and T4 level within 3 months of the dose change to ensure that the patient does not become hyperthyroid.
    • Stable dosage of thiazide for at least 3 consecutive months.
  • All patients must stop the following therapies at least 4 weeks prior to the screening visit and remain off these therapies for the remainder of the clinical trial. Screening laboratories must be performed after the washout is complete. However, imaging studies (BMD, X-rays) may be performed prior to starting the calcitonin, estrogen, and selective estrogen receptor modulation (SERM) washout.

    • Calcitonin
    • Estrogen replacement therapy by oral, transdermal or intramuscular administration
    • SERM drugs, e.g., tamoxifen, raloxifene, Evista
    • Vaginal application of estrogen-containing creams unless the dose is conjugated estrogen or estradiol: maximum of 0.5 g twice each week (total of 1.0 g weekly); or Estrace (Ogen): maximum of 1.0 g twice each week (total of 2.0 g weekly).
    • Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade [infliximab])
    • The drug class tetracyclines
    • Medication known to affect the metabolism of bone (the Principal Investigator should discuss this with the Project Medical Officer before the patient is excluded from enrollment)

E. Miscellaneous Concurrent Medications:

  • Methotrexate - The antimetabolite, methotrexate, which interferes with DNA synthesis, repair and cellular replication should not be used by patients participating in this Phase III study. In general, immunomodulatory agents with antiproliferative activity are not permitted as a concomitant medication in this Phase III study.
  • Intra-articular injections - Patients with chronic, active joint disease should be excluded from this Phase III study. Patients may receive a maximum of one intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this Phase III study. The dose of corticosteroid injected should not exceed the anti-inflammatory equivalent dose of prednisone 40 mg suspension. The dose and volume should be adjusted downward as appropriate to the size of the joint.
  • Provera is an acceptable concomitant medication when used according to the label instructions.

F. Laboratory Values and Physical Examination Findings:

  • Serum calcium greater than 10.7 mg/dL (2.66 mmol/L). At screening, if the serum calcium is abnormal, the patient may have the additional evaluation described below ONCE:

    1. Discontinue all oral calcium and vitamin D3 supplements.
    2. Repeat a fasting serum calcium level two weeks later.
    3. If the fasting serum calcium level is still abnormal, the patient is discontinued from the study.
    4. If the repeat fasting serum calcium is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
  • Serum creatinine > 1.5 mg/dL (132.6 mmol/L)
  • Urinary calcium to creatinine ratio is greater than or equal to 1. At screening, if a patient's urinary calcium to creatinine ratio is abnormal, the patient may have the additional evaluation described below ONCE:

    1. Discontinue all oral calcium and vitamin D3 supplements.
    2. Repeat a fasting urine calcium to creatinine ratio two weeks later.
    3. If the fasting urinary calcium to creatinine ratio is still abnormal, the patient is discontinued from the study.
    4. If the repeat fasting urinary calcium to creatinine ratio is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
  • Total serum alkaline phosphatase >130 U/L except as noted - Argentina (311 U/L); Brazil (278 U/L); Mexico (159 U/L).
  • Any other clinically significant abnormal value as judged by the investigator
  • Body weight below 40 kg

G. Substance Abuse:

  • Alcohol and/or drug abuse

H. Psychiatric Disease:

  • Current or history of psychiatric disease that would interfere with the ability to comply with the clinical trial protocol

I. Compliance:

  • Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172081

  Hide Study Locations
Locations
United States, Alabama
Capstone Clinical Trials
Birmingham, Alabama, United States, 35205
'The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
'Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
'Radiant Research - Phoenix
Phoenix, Arizona, United States, 85013
United States, California
'Robin K. Dore, M.D., Inc.
Anaheim, California, United States, 92801
'Osteoporosis Medical Center
Beverly Hills, California, United States, 90211
'East Bay Clinical Trial Center
Concord, California, United States, 94520
'Loma Linda Osteoporosis Research Center
Loma Linda, California, United States, 92354
'The Foundation for Osteoporosis Research and Education
Oakland, California, United States, 94612
'Desert Medical Advances
Palm Desert, California, United States, 92260
'VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
'Boling Clinical Trials
Rancho Cucamonga, California, United States, 91730
'S.D. Arthritis & Osteoporosis Medical Clinic
san Diego, California, United States, 92120
'Radiant Research - San Diego
San Diego, California, United States, 92108
'San Francisco General Hospital
San Francisco, California, United States, 94110
'Community Research Centers
Santa Ana, California, United States, 92701
United States, Colorado
'Denver Arthritis Clinic
Denver, Colorado, United States, 80220
'Colorado Center for Bone Research
Lakewood, Colorado, United States, 80227
'Longmont Medical Research Network
Longmont, Colorado, United States, 80501
United States, Connecticut
'Northeast Clinical Research, LLC
Hamden, Connecticut, United States, 06518
United States, District of Columbia
'Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
'RASF - Clinical Research Center
Boca Raton, Florida, United States, 33486
'ICSL Clinical Studies
Fort Myers, Florida, United States, 33907
'The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
'Florida Wellcare Alliance
Inverness, Florida, United States, 34452
'Radiant Research - Lake Worth
Lake Worth, Florida, United States, 33461
'Osteoporosis Center University of Miami
Miami, Florida, United States, 33136
'Renstar Medical Group
Ocala, Florida, United States, 34471
'Diabetes and Endocrinology Treatment Center
Palm Beach Gardens, Florida, United States, 33410
'The Arthritis Center
Palm Harbor, Florida, United States, 34684
'The Centre for Arthritis and Rheumatic Diseases
South Miami, Florida, United States, 33143
'ICSL Clinical Studies
St. Petersburg, Florida, United States, 33702
'Radiant Research - Stuart & LakeWorth
Stuart, Florida, United States, 34996
'Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
'The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Hawaii
'Radiant Research
Honolulu, Hawaii, United States, 96814
United States, Idaho
'Intermountain Orthopaedics
Boise, Idaho, United States, 83702
United States, Illinois
'ICSL-Clinical Studies
Bloomington, Illinois, United States, 61704
Rush-Prebyterian-St.Luke's Medical Center
Chicago, Illinois, United States, 60612
'The University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
'University Hospital & Outpatient Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
'Mercy Arthritis and Osteoporosis Center
Des Moines, Iowa, United States, 50322
United States, Kansas
'Wichita Clinic
Wichita, Kansas, United States, 67208
United States, Louisiana
'Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maine
'Maine Center for Osteoporosis Research & Education
Bangor, Maine, United States, 04401
United States, Maryland
'Bethesda Health Research Center
Bethesda, Maryland, United States, 20817
'The Osteoporosis and Clinical Trials Center
Cumberland, Maryland, United States, 21502
'Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, United States, 21702
'The Osteoporosis and Clinical Trials Center
Hagerstown, Maryland, United States, 21740
'The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, Massachusetts
'Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
'Phase III Clinical Research
Fall River, Massachusetts, United States, 02720
'Osteoporosis Research & Treatment Center
Worcester, Massachusetts, United States, 01605
United States, Michigan
'Michigan Bone & Mineral Clinic
Detroit, Michigan, United States, 48236
United States, Mississippi
'Desoto Family Medical Center
Olive Branch, Mississippi, United States, 38654
United States, Missouri
'St. John's Medical Research Group
Springfield, Missouri, United States, 65807
United States, Nevada
'VA Southern NV Healthcare Systems
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
'Arthritis, Osteoporosis Muscle Skeletal Disease Center
Concord, New Hampshire, United States, 03301
United States, New Jersey
'Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
'Anderson and Collins Clinical Research Inc.
South Plainfield, New Jersey, United States, 07080
United States, New Mexico
'New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, United States, 87106
'Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
'Bone Mineral Research Center
Mineola, New York, United States, 11501
'College of Physicians and Surgeons, Columbia University
New York, New York, United States, 10032
'Beth Israël Medical Center
New York, New York, United States, 10003
'Rochester Clinical Research Inc.
Rochester, New York, United States, 14609
'Stony Brook Clinical Research Trials Center
Stony Brook, New York, United States, 11794
'Physicians Clinical Research Services
White Plains, New York, United States, 10605
United States, North Carolina
'Carolina Bone and Joint - Charlotte
Charlotte, North Carolina, United States, 28210
'Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, North Dakota
'Odyssey Research Services
Bismarck, North Dakota, United States, 58501
Michael J. Lillestol
Fargo, North Dakota, United States, 58103
'Altru Health Systems/Altru Research Center
Grand Forks, North Dakota, United States, 58201
'Odyssey Research Services
Minot, North Dakota, United States, 58701
United States, Ohio
'Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
'David R. Mandel M.D. Inc.
Mayfield Village, Ohio, United States, 44143
United States, Oklahoma
'Oklahoma Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma, United States, 74114
United States, Oregon
'Osteoporosis Center
Medford, Oregon, United States, 97504
United States, Pennsylvania
'Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
'Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19131
'University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
'Clinical Research Center of Reading LLP
West Reading, Pennsylvania, United States, 19611
'Radiant Research
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
'Rhode Island Hospital
Providence, Rhode Island, United States, 02903
'Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
United States, South Carolina
'Radiant Research
Anderson, South Carolina, United States, 29621
'Columbia Arthritis Center, PA
Columbia, South Carolina, United States, 29204
'Radiant Research
Greer, South Carolina, United States, 29651
United States, South Dakota
'Rapid City Medical Center
Rapid City, South Dakota, United States, 57701
'Averna Research Institute
Sioux Falls, South Dakota, United States, 57105
'Brown Clinic
Watertown, South Dakota, United States, 57201
United States, Tennessee
'Clinsearch
Chattanooga, Tennessee, United States, 37404
United States, Texas
'Radiant Research/Dallas
Dallas, Texas, United States, 75235
'Breco Research Inc.
Houston, Texas, United States, 77024
'Diabetes Center of the Southwest
Midland, Texas, United States, 79705
'Radiant Research San Antonio
San Antonio, Texas, United States, 78229
'Diabetes & Glandular Disease Research Associates, P.A.
San Antonio, Texas, United States, 78229
United States, Utah
'Salt Lake Women's Center
Sandy, Utah, United States, 84070
United States, Vermont
'Fletcher Allan Health Center, UHC Campus 1
Burlington, Vermont, United States, 05401
United States, Virginia
'Center for Arthritis and Diabetes
Newport News, Virginia, United States, 23606
'MCV Physicians Program for Osteoporosis
Richmond, Virginia, United States, 23298
'National Clinical Research, Inc.
Richmond, Virginia, United States, 23294
United States, Washington
'South Puget Sound Clinical Research Center
Olympia, Washington, United States, 98502
'Osteoporosis Research Group
Seattle, Washington, United States, 98105
Phillip J. Mease
Seattle, Washington, United States, 98104
United States, Wisconsin
'University of Wisconsin Medical Foundation
Madison, Wisconsin, United States, 53792
'Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
'IDIM
Buenos Aires, BUE, Argentina, C1012AAR
'Centro Médico T.I.E.M.P.O
Buenos Aires, BUE, Argentina, C1117ABH
'Hospital Ramos Mejía
Buenos Aires, BUE, Argentina, C1221ADC
'Centro de Osteopatias Medicas
Capital Federal, CBA, Argentina, C1114AAI
Brazil
'Universidade Federal de Pernambuco
Recife, PE, Brazil, 50670
'Universidade Federal do Paraná
Curitiba, PR, Brazil, 80060
'Hospital Santa Casa de Misericórdia do Rio de Janeiro
'Rio de Janeiro, RJ, Brazil, 20020
'Hospital do Servidor Público do Rio de Janeiro
Rio de Janeiro, RJ, Brazil, 20221
'UNICAMP
Campinas, SP, Brazil, 13083
'Pontifícia Universidade Católica de Campinas
Campinas, SP, Brazil
'Hospital Heliópolis
Sao Paulo, SP, Brazil, 04231
'Hospital Santa Casa de Misericórdia de São Paulo
Sao Paulo, SP, Brazil, 01221
'Instituto de Saúde e Bem Estar da Mulher
Sao Paulo, SP, Brazil, 04062
'Universidade Federal de São Paulo
Sao Paulo, SP, Brazil, 04038
Bulgaria
'Multifunctional Hospital for Active Treatment "Sv.Georgy"
Plovdiv, Bulgaria, 4002
'SHATGO"Sheynovo"
Sofia, Bulgaria, 1504
'Multifunctional Hospital for Active Treatment "Alexandrovska
Sofia, Bulgaria, 1431
'Multifunctional Hospital for Active Treatment "Sv.Ivan Rilsky"
Sofia, Bulgaria, 1431
'SHATENG"Acad.Ivan Penchev"
Sofia, Bulgaria, 1303
Canada, Alberta
'Heritage Medical Research Clinic
Calgary, Alberta, Canada, 'T2N 4N1
Canada, British Columbia
Osteoporosis Research Center
Vancouver, British Columbia, Canada, V5Z 2N6
Canada, Manitoba
'Manitoba Clinic
Winnipeg, Manitoba, Canada, 'R3A 1M3
Canada, Ontario
Charlton Medical Centre
Hamilton, Ontario, Canada, L8N 1Y2
Rafat Faraawi
Kitchener, Ontario, Canada, N2M 5N6
St. Joseph's Health Centre
London, Ontario, Canada, N6A 4V2
'Centre for Activity and Aging
London, Ontario, Canada, 'N6G 2M3
'Royal Victoria Hospital
Montreal, Ontario, Canada, 'H3A 1A1
Oakville Bone Center
Oakville, Ontario, Canada, L6J 1X8
Ottawa Hospital
Ottawa, Ontario, Canada, 'K1H 8L6
'Osteoporosis Research Program
Toronto, Ontario, Canada, 'M5S 1B2
'Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada, 'M4N 3M5
'St. Michael's Hospital
Toronto, Ontario, Canada, 'M5C 2T2
Jude F. Rodrigues
Windsor, Ontario, Canada, N8W 5L7
Canada, Prince Edward Island
'Riverside Medical Centre
Charlottetown, Prince Edward Island, Canada, C1A 6A4
Canada, Quebec
'Complexe Hospitalier de la Sagami
Chicoutimi, Quebec, Canada, G7H 5H6
'Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, 'H1T 2M4
'Centre de Recherche du CHUM - Hopital Saint-Luc
Montreal, Quebec, Canada, 'H2X 1P1
'Centre d'Etude Clinique Montreal Inc.
Montreal, Quebec, Canada, 'H1T 1P6
Centre de Recherche - CORQ
Sainte-Foy, Quebec, Canada, G1V 3M7
Novabyss Research Clinic
Sherbrooke, Quebec, Canada, J1J 2B8
Canada, Saskatchewan
'Saskatoon Osteoporosis Centre
'Saskatoon, Saskatchewan, Canada, 'S7K 0H6
Israel
'Clalit Health Services
Beer Sheva, Israel, 84894
'Soroka Medical Center
Beer Sheva, Israel, 84101
'Hillel Yaffe Medical Center
Hadera, Israel, 38101
'Rambam Medical Center
Haifa, Israel, 31096
'Lin Medical Center
Haifa, Israel, 34162
'Hadassah University Hospital
Jerusalem, Israel, 91240
'Rabin Medical Center
Petach Tikva, Israel, 49100
'Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
'Lis Maternity Hospital
Tel Aviv, Israel
Mexico
'Hospital Clinical del Parque
Chihuahua, Chih, Mexico, 31020
'Hospital de Mexico
Mexico, DF, Mexico, 11800
'Instituto Mexicano de Investigacion Clinica
Mexico, DF, Mexico, 06700
'Osteosol
Mexico, DF, Mexico, 06100
'Hospital Angeles de las Lomas
'Huixquilucan, Emex, Mexico, 52763
'Hospital Aranda de la Parra
Leon, GTO, Mexico, 37000
'Medica Monraz
Guadalajara, JAL, Mexico, 44670
'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, JAL, Mexico, 44340
'Hospital Civil de Belem
Guadalajara, JAL, Mexico, 44650
'Hospital Central "Ignacio Morones Prieto"
'San Luis Potosi, SLP, Mexico, 78240
'Hospital Universitario de Monterrey
Monterrey Nuevo Leon, Mexico, 64040
Romania
'CLINTRIAL "DORIS" Medical Centre
Bucuresti, Romania, 772021
'Centrul Medical Sabyc
Bucuresti, Romania
'Spitalul Clinic Judetean Cluj-Napoca
Cluj-Napoca, Romania, 3400
Russian Federation
'Russian Academy for Advanced Medical Studies
Moscow, Russian Federation, 125315
'Scientific Center of Endocrinology of RAMS
Moscow, Russian Federation, 117036
'JK "Medicine"
Moscow, Russian Federation, 125047
Sponsors and Collaborators
NPS Pharmaceuticals
  More Information

No publications provided by NPS Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00172081     History of Changes
Other Study ID Numbers: ALX1-11-93001
Study First Received: September 9, 2005
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:
Post-menopausal
Osteoporosis
Parathyroid Hormone
PTH
ALX1-11

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014