A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
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ClinicalTrials.gov Identifier: NCT01292187 |
Recruitment Status :
Completed
First Posted : February 9, 2011
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | February 7, 2011 | |||
First Posted Date ICMJE | February 9, 2011 | |||
Results First Submitted Date ICMJE | July 11, 2013 | |||
Results First Posted Date ICMJE | September 12, 2014 | |||
Last Update Posted Date | September 12, 2014 | |||
Study Start Date ICMJE | January 2011 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo. [ Time Frame: Baseline, Week 54 ] | |||
Original Primary Outcome Measures ICMJE |
Effect of rsCT compared to placebo on BMD of the lumbar spine, as assessed by DXA at Week 54. [ Time Frame: Week 54 ] | |||
Change History | Complete list of historical versions of study NCT01292187 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo. [ Time Frame: Baseline, Week 54 ] | |||
Original Secondary Outcome Measures ICMJE |
Effect of rsCT compared to placebo on various areas of the body. [ Time Frame: Weeks 28 and 54 ]
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Osteopenia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
129 | |||
Original Estimated Enrollment ICMJE |
120 | |||
Actual Study Completion Date ICMJE | July 2012 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years and older (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 | NCT01292187 | |||
Other Study ID Numbers ICMJE | TAR-01-201 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Tarsa Therapeutics, Inc. | |||
Study Sponsor ICMJE | Tarsa Therapeutics, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Tarsa Therapeutics, Inc. | |||
Verification Date | September 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |