Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
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|ClinicalTrials.gov Identifier: NCT03710889|
Recruitment Status : Completed
First Posted : October 18, 2018
Results First Posted : October 15, 2021
Last Update Posted : October 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis, Postmenopausal Osteoporosis Osteoporosis Vertebral Osteoporosis Risk Osteoporosis Fracture Osteoporosis Localized to Spine Osteoporosis, Age-Related Osteoporosis Senile Osteoporosis of Vertebrae||Drug: Abaloparatide||Phase 3|
This was an open-label, single-arm study of postmenopausal women with osteoporosis treated with 80 micrograms (μg) abaloparatide for 3 months. Transiliac bone biopsies were taken at 3 months after quadruple fluorochrome labeling. The treatment duration of 3 months was determined to be the optimal time when biochemical markers of bone turnover peak and are predictive of subsequent changes in bone mineral density (BMD).
The main study was conducted for a 3-month treatment period with a 1-month follow up. A sub-study was conducted at 1 site to collect peripheral quantitative computed tomography (pQCT) data. Study treatment for participants in the sub-study was extended for an additional 3 months of study drug administration for a total of 6 months of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption|
|Actual Study Start Date :||September 20, 2018|
|Actual Primary Completion Date :||July 15, 2020|
|Actual Study Completion Date :||July 15, 2020|
Participants self-administered a single daily dose of 80 micrograms (µg) of abaloparatide subcutaneously (SC) during the treatment period. Participants were instructed to use a new injection pen after each 30-day period.
Abaloparatide is a novel, synthetic, 34 amino acid peptide designed to be a potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor (PTHR1) signaling pathway with 41% homology to PTH[1-34] and 76% homology to human PTHrP[1-34].
- Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3 [ Time Frame: Baseline (Day 1), Month 3 ]Change in dynamic histomorphometry indices was assessed in the cancellous envelope.
- Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3 [ Time Frame: Baseline (Day 1), Month 3 ]Change in dynamic histomorphometry indices was assessed in the cancellous envelope. BFR/BS was reported as cubic millimeter/square millimeter/year (mm^3/mm^2/year).
- Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3 [ Time Frame: Baseline (Day 1), Months 1 and 3 ]Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3.
- Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3 [ Time Frame: Baseline (Day 1), Months 1 and 3 ]Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710889
|United States, Colorado|
|Panorama Orthopedics & Spine Center|
|Golden, Colorado, United States, 80401|
|United States, Georgia|
|Center for Advanced Research & Education|
|Gainesville, Georgia, United States, 30501|
|United States, Massachusetts|
|Harvard Medical School|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48230|
|Study Director:||Medical Director||Radius Health, Inc.|