Trials / Completed
CompletedNCT03710889
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Radius Health, Inc. · Industry
- Sex
- Female
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.
Detailed description
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.
Conditions
- Osteoporosis, Postmenopausal
- Osteoporosis
- Osteoporosis Vertebral
- Osteoporosis Risk
- Osteoporosis Fracture
- Osteoporosis Localized to Spine
- Osteoporosis, Age-Related
- Osteoporosis Senile
- Osteoporosis of Vertebrae
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abaloparatide | 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\[1-34\]. |
Timeline
- Start date
- 2018-09-20
- Primary completion
- 2020-07-15
- Completion
- 2020-07-15
- First posted
- 2018-10-18
- Last updated
- 2021-10-15
- Results posted
- 2021-10-15
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03710889. Inclusion in this directory is not an endorsement.