Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3
| Group | Value (percentage of MS/BS) | Spread |
|---|---|---|
| Abaloparatide | 5.74 | 3.978 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
NCT0371088920 Sept 2018 to 15 Jul 2020
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Abaloparatide
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.
Outcomes the sponsor listed as primary.
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of MS/BS) | Spread |
|---|---|---|
| Abaloparatide | 5.74 | 3.978 |
| Group | Value (mm^3/mm^2/year) | Spread |
|---|---|---|
| Abaloparatide | 0.011 | 0.0076 |
| Group | Value (nanograms (ng)/milliliter (mL)) |
|---|---|
| Abaloparatide | 54.990 |
| Group | Value (ng/mL) |
|---|---|
| Abaloparatide | 0.460 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| AbaloparatideParticipants self-administered a single daily dose of 80 µg of abaloparatide SC during the treatment period. Participants were instructed to use a new injection pen after each 30-day period. | 0 / 23 | 2 / 23 | 18 / 23 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
Indexing hint: Clinical trial · 2021
Dempster et al. 2021Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 27
PMID 33434314PMC8248188DOI 10.1002/jbmr.4243PUB-33434314
Indexing hint: Randomized controlled trial · 2017
Cosman et al. 2017Mayo Clinic proceedingscited by 96
PMID 28160873DOI 10.1016/j.mayocp.2016.10.009PUB-28160873
Indexing hint: Observational study · 2016
Hattersley et al. 2016Endocrinologycited by 231
PMID 26562265PMC4701881DOI 10.1210/en.2015-1726PUB-26562265
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