Trial · NCT03710889
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
NCT03710889, Phase 3, Completed, Radius Health, Inc.; results first posted 2021-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption. Trials, record NCT03710889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03710889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
- NCT number
- NCT03710889
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- Radius Health, Inc.
- Conditions
Osteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral, Osteoporosis Risk, Osteoporosis Fracture, Osteoporosis Localized to Spine, Osteoporosis, Age-Related, Osteoporosis Senile, Osteoporosis of Vertebrae
- Interventions
- Abaloparatide
- First posted
- 2018-10-18
- Last updated
- 2021-10-15
- Results first posted
- 2021-10-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3 | Baseline (Day 1), Month 3 | Change in dynamic histomorphometry indices was assessed in the cancellous envelope. |
| Secondary | Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3 | 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). |
| Secondary | Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3 | 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. |
| Secondary | Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3 | Baseline (Day 1), Month 3 | The Bone-Biopsy Population included all participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | percentage of MS/BS | MEAN |
| SECONDARY | Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3 | Baseline (Day 1), Month 3 | The Bone-Biopsy Population included all participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | mm^3/mm^2/year | MEAN |
| SECONDARY | Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3 | Baseline (Day 1), Months 1 and 3 | The Bone-Biopsy Population included all enrolled participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Number Analyzed' signifies participants evaluable for the specified categories. | nanograms (ng)/milliliter (mL) | MEDIAN |
| SECONDARY | Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3 | Baseline (Day 1), Months 1 and 3 | The Bone-Biopsy Population included all enrolled participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Number Analyzed' signifies participants evaluable for the specified categories. | ng/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3 | Abaloparatide | Baseline | 5.74 | Standard Deviation 3.978 | percentage of MS/BS |
| Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3 | Abaloparatide | Change at Month 3 | 18.66 | Standard Deviation 12.114 | percentage of MS/BS |
| Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3 | Abaloparatide | Baseline | 0.011 | Standard Deviation 0.0076 | mm^3/mm^2/year |
| Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3 | Abaloparatide | Change at Month 3 | 0.034 | Standard Deviation 0.0245 | mm^3/mm^2/year |
| Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3 | Abaloparatide | Baseline | 54.990 | Inter-Quartile Range 38.430 to 79.160 | nanograms (ng)/milliliter (mL) |
| Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3 | Abaloparatide | Change at Month 1 | 119.155 | Inter-Quartile Range 62.810 to 242.240 | nanograms (ng)/milliliter (mL) |
| Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3 | Abaloparatide | Change at Month 3 | 141.130 | Inter-Quartile Range 53.420 to 236.980 | nanograms (ng)/milliliter (mL) |
| Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3 | Abaloparatide | Baseline | 0.460 | Inter-Quartile Range 0.308 to 0.549 | ng/mL |
| Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3 | Abaloparatide | Change at Month 1 | 0.052 | Inter-Quartile Range -0.109 to 0.174 | ng/mL |
| Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3 | Abaloparatide | Change at Month 3 | 0.311 | Inter-Quartile Range 0.079 to 0.694 | ng/mL |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abaloparatide | 23 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Abaloparatide | 23 | |
| Overall Study | Bone-Biopsy Population | Abaloparatide | 19 | |
| Overall Study | COMPLETED | Abaloparatide | 20 | |
| Overall Study | NOT COMPLETED | Abaloparatide | 3 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Abaloparatide | 2 | 23 | |
| other | Nausea | Gastrointestinal disorders | Abaloparatide | 4 | 23 | |
| other | Upper respiratory tract infection | Infections and infestations | Abaloparatide | 2 | 23 | |
| other | Fall | Injury, poisoning and procedural complications | Abaloparatide | 2 | 23 | |
| other | Bursitis | Musculoskeletal and connective tissue disorders | Abaloparatide | 3 | 23 | |
| other | Dizziness | Nervous system disorders | Abaloparatide | 4 | 23 | |
| other | Headache | Nervous system disorders | Abaloparatide | 3 | 23 | |
| other | Wheezing | Respiratory, thoracic and mediastinal disorders | Abaloparatide | 2 | 23 | |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | Abaloparatide | 2 | 23 | |
| serious | Atrial fibrillation | Cardiac disorders | Abaloparatide | 1 | 23 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abaloparatide | 0 | 23 |
| Total, other adverse events | Abaloparatide | 18 | 23 |
| Total, serious adverse events | Abaloparatide | 2 | 23 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03710889
GET https://conductscience.org/api/trials/v1/NCT03710889/registered