Trial record 2 of 6 for:    tarsa

A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01292187
First received: February 7, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.


Condition Intervention Phase
Osteopenia
Drug: Oral calcitonin at dinnertime
Drug: Oral placebo at dinnertime
Drug: Oral calcitonin at bedtime
Drug: Oral placebo at bedtime
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of Oral Recombinant Salmon Calcitonin (rsCT) in the Prevention of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture

Resource links provided by NLM:


Further study details as provided by Tarsa Therapeutics, Inc.:

Primary Outcome Measures:
  • Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo. [ Time Frame: Baseline, Week 54 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo. [ Time Frame: Baseline, Week 54 ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral calcitonin at dinner-or bedtime
Intervention: Oral calcitonin at dinnertime or oral calcitonin at bedtime. Postmenopausal subjects with osteopenia were treated for one year (also with vitamin D and calcium supplements) to determine if oral calcitonin tablets would prevent the loss of bone mineral density compared with placebo. Randomization to active or placebo was done 2:1. After randomization, further randomization was done to divide each arm into two groups, one in which dosing was at dinnertime and the other in which dosing was at bedtime to determine if food affected efficacy or safety.
Drug: Oral calcitonin at dinnertime
Oral calcitonin at dinnertime.
Other Name: Oral rsCT
Drug: Oral calcitonin at bedtime
Oral calcitonin at bedtime
Other Name: Oral rsCT
Experimental: Oral placebo at dinner- or bedtime
Intervention: oral placebo at dinnertime or oral placebo at bedtime
Drug: Oral placebo at dinnertime
Oral placebo at dinnertime.
Other Name: Placebo
Drug: Oral placebo at bedtime
Oral placebo at bedtime
Other Name: Placebo

Detailed Description:

This was a randomized, double-blind, placebo-controlled Phase 2 study conducted entirely in the US. The subjects were all post-menopausal women whose 10-year risk of major osteoporotic fracture was assessed using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX®) algorithm within the first 3 visits. Eligible, consenting subjects were then enrolled and began a 2- week single-blind placebo run-in phase to determine tolerability. After the run-in phase, continuing subjects were randomized in a 2:1 ratio to receive oral calcitonin or placebo. All subjects took 600 mg calcium citrate and 1000 IU vitamin D once daily with breakfast beginning with the run-in phase. The duration of treatment including the run-in phase was 54 weeks. Bone mineral density (BMD) and C-terminal telopeptide of type 1 collagen (CTx-1) were determined at Baseline and Weeks 28 and 54 after randomization. The % change from baseline in lumbar spine BMD was calculated and compared: active to placebo. The change from baseline in plasma CTx-1 was also calculated and compared likewise.

To confirm that there is no effect of meal timing on this product, subjects in both arms were further randomized to take the active or placebo on an empty stomach at bedtime or with the meal at dinnertime.

  Eligibility

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

Inclusion Criteria:

  • Female and at least 45 years of age.
  • Must have undergone the onset of spontaneous or surgical menopause more than 5 years prior to entry. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea. Surgical menopause is defined as ≥ 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
  • Serum follicle-stimulating hormone (FSH) levels must be ≥ 30 mIU/mL.
  • A body mass index (BMI) of not greater than 35 (BMI

    =weight [kg]/height[m]2).

  • Bone mineral density (BMD) T-score between -1.0 and - 2.5 at the total hip, femoral neck, trochanter, or lumbar spine.
  • Additional risk factors such that the 10 year risk of a major osteoporotic fracture or hip fracture risk is at least as great as a 65-year-old woman of the same race and BMI of 25 kg/m2 as determined by the FRAX algorithm .
  • No clinically significant abnormal findings in the medical history or physical exam that would preclude participation in the investigator's opinion.
  • No clinically significant abnormal laboratory values at the screening assessment.
  • Subjects must give written informed consent after reading the Subject Information and Consent Form and having had the opportunity to discuss the study with the investigator.

Exclusion Criteria:

  • History of an osteoporotic fracture, defined as a fracture at the wrist, hip, or humerus occurring from a fall at standing height or less.
  • BMD T-Score at any site ≤ -2.5.
  • Current treatment (or within 3 months prior to randomization) with hormone replacement therapy.
  • History of metabolic and other bone diseases, including osteogenesis imperfecta, osteomalacia, and Paget's disease.
  • Vitamin D insufficiency defined as a 25 hydroxyvitamin D level < 20 ng/mL (50 nmol/L).
  • Prior use of calcitonin, ever.
  • Prior use of any bisphosphonate, ever.
  • Prior use of denosumab, fluoride, or strontium, ever.
  • Prior use of parathyroid hormone analogs, ever.
  • Any condition or disease that may interfere with the ability to have a dual energy x-ray absorptiometry (DXA) scan or to evaluate a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, bilateral hip replacements.
  • Use of anabolic steroids or androgens within 6 months preceding randomization.
  • Use of vitamin D metabolites and analogs, (e.g., calcitriol) within 3 months preceding randomization). Note: Vitamin D supplementation is not exclusionary.
  • Use of estrogen or estrogen-related drugs (including selective estrogen receptor molecules), for example, tamoxifen, tibolone, or raloxifene within 3 months preceding randomization.
  • Chronic systemic treatment with glucocorticoids.
  • Clinically relevant abnormal history, physical findings, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the subject.
  • Presence of acute or chronic illness or history of chronic illness which, in the judgment of the investigator, makes participation in the study medically inappropriate.
  • Known acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) seropositivity.
  • Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled diabetes mellitus, significant coronary heart disease, any psychotic mental illness, chronic allergic rhinitis, asthma, uncorrected endocrine dysfunction, or significantly impaired hepatic, respiratory, or renal function.
  • Participation in any other clinical study within the previous month.
  • History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly.
  • Possibility that the subject will not cooperate with the requirements of the protocol.
  • Known sensitivity to sCT.
  • Shift workers-individuals who are at work during overnight hours.
  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: NCT01292187

Locations
United States, California
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States, 33756
United States, Maryland
Bethesda Health Research
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
Michigan Bone and Mineral Clinic
Detroit, Michigan, United States, 48236
United States, Missouri
The Osteoporosis Center at St. Luke's Hospital
Chesterfield, Missouri, United States, 63107
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, Pennsylvania
University of Pittsburgh - Department of Neurology
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Puget Sound Osteoporosis Center
Seattle, Washington, United States, 98144
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Tarsa Therapeutics, Inc.
Investigators
Study Director: David S. Krause, MD Chief Medical Officer - Tarsa Therapeutics, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01292187     History of Changes
Other Study ID Numbers: TAR-01-201
Study First Received: February 7, 2011
Results First Received: July 11, 2013
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tarsa Therapeutics, Inc.:
Osteoporosis
Osteopenia
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Salmon calcitonin
Calcitonin

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Calcitonin
Calcitonin Gene-Related Peptide
Salmon calcitonin
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 30, 2014