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Alendronate and/or Parathyroid Hormone for Osteoporosis

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ClinicalTrials.gov Identifier: NCT00000400
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : December 9, 2013
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Robert M. Neer, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 3, 1999
First Posted Date  ICMJE November 4, 1999
Last Update Posted Date December 9, 2013
Study Start Date  ICMJE August 1999
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
change in spine bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
  • change in hip bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in forearm bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in total body bone mineral [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in femoral shaft bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in serum PINP [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • change in serum osteocalcin [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • change in serum NTX [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of hypercalcemia [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of hypercalciuria [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of symptoms [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alendronate and/or Parathyroid Hormone for Osteoporosis
Official Title  ICMJE Bone Formation-Resorption Coupling and Osteoporosis
Brief Summary This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
Detailed Description

This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).

Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.

Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.

During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Human parathyroid hormone [hPTH-(1-34)]
    37 mcg once daily by self-administered sc injection
    Other Name: teriparatide
  • Drug: alendronate
    70 mg/week by oral route
    Other Name: Fosamax
Study Arms  ICMJE
  • Experimental: PTH
    Human parathyroid hormone [hPTH-(1-34)]
    Intervention: Drug: Human parathyroid hormone [hPTH-(1-34)]
  • Active Comparator: ALN
    Alendronate
    Intervention: Drug: alendronate
  • Experimental: PTH+ALN
    Human parathyroid hormone [hPTH-(1-34)] plus alendronate
    Interventions:
    • Drug: Human parathyroid hormone [hPTH-(1-34)]
    • Drug: alendronate
Publications * Finkelstein JS, Wyland JJ, Leder BZ, Burnett-Bowie SM, Lee H, Jüppner H, Neer RM. Effects of teriparatide retreatment in osteoporotic men and women. J Clin Endocrinol Metab. 2009 Jul;94(7):2495-501. doi: 10.1210/jc.2009-0154. Epub 2009 Apr 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2008)
176
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
108
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Lumbar spine or hip BMD T-score less than or equal to minus 2.0
  • Postmenopausal at least 5 years
  • Fully ambulatory
  • Able to give informed consent

Exclusion Criteria:

  • No concurrent illnesses that cause bone loss
  • No recent drug treatment for osteoporosis
  • No recent fracture
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000400
Other Study ID Numbers  ICMJE P50 AR44855 NIAMS-023
P50AR044855 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert M. Neer, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Robert M. Neer, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP