Trial · NCT03512262
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
NCT03512262, Phase 3, Completed, Radius Health, Inc.; results first posted 2023-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM). Trials, record NCT03512262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03512262
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
- NCT number
- NCT03512262
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 228 participants, actual
- Lead sponsor
- Radius Health, Inc.
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis, Osteoporosis Senile, Osteoporosis of Vertebrae
- Interventions
- Abaloparatide, Placebo
- First posted
- 2018-04-30
- Last updated
- 2023-04-07
- Results first posted
- 2023-04-07
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Baseline, Month 12 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 | Baseline, Month 12 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 12 | Baseline, Month 12 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Baseline, Month 6 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change in Total Hip BMD From Baseline at Month 6 | Baseline, Month 6 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 6 | Baseline, Month 6 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12 | Baseline, Month 12 | Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Distal One-third Radius BMD at Month 12 | Baseline, Month 12 | Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. |
| Secondary | Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12 | Baseline, Month 12 | Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone. |
| Secondary | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12 | Baseline, Month 12 | Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Baseline, Month 12 | Intent-to-Treat (ITT) Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Baseline, Month 6 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Total Hip BMD From Baseline at Month 6 | Baseline, Month 6 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck BMD at Month 6 | Baseline, Month 6 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Distal One-third Radius BMD at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had s-PINP evaluation at Baseline and Month 12. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12 | Baseline, Month 12 | ITT Population: All participants randomized into the study. Here, overall number of participants analyzed is the total number of participants who had s-CTX evaluation at Baseline and Month 12. | percent change | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Abaloparatide | 8.4820 | Standard Error 0.5353 | percent change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Placebo | 1.1654 | Standard Error 0.7235 | percent change | |
| Percent Change From Baseline in Total Hip BMD at Month 12 | Abaloparatide | 2.1351 | Standard Error 0.2711 | percent change | |
| Percent Change From Baseline in Total Hip BMD at Month 12 | Placebo | 0.0143 | Standard Error 0.3543 | percent change | |
| Percent Change From Baseline in Femoral Neck BMD at Month 12 | Abaloparatide | 2.9766 | Standard Error 0.3448 | percent change | |
| Percent Change From Baseline in Femoral Neck BMD at Month 12 | Placebo | 0.1545 | Standard Error 0.4527 | percent change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Abaloparatide | 5.5436 | Standard Error 0.4127 | percent change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Placebo | 0.6418 | Standard Error 0.5472 | percent change | |
| Percent Change in Total Hip BMD From Baseline at Month 6 | Abaloparatide | 1.3888 | Standard Error 0.2142 | percent change | |
| Percent Change in Total Hip BMD From Baseline at Month 6 | Placebo | 0.0267 | Standard Error 0.2790 | percent change |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abaloparatide | 149 | |
| Overall Study | STARTED | Placebo | 79 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Abaloparatide | 149 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 79 | |
| Overall Study | COMPLETED | Abaloparatide | 114 | |
| Overall Study | COMPLETED | Placebo | 64 | |
| Overall Study | NOT COMPLETED | Abaloparatide | 35 | |
| Overall Study | NOT COMPLETED | Placebo | 15 |
Source ClinicalTrials.gov
Adverse events54
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 | Injection site erythema | General disorders | Abaloparatide | 19 | 149 | |
| other | Injection site erythema | General disorders | Placebo | 4 | 79 | |
| other | Injection site swelling | General disorders | Abaloparatide | 10 | 149 | |
| other | Injection site swelling | General disorders | Placebo | 0 | 79 | |
| other | Injection site pain | General disorders | Abaloparatide | 9 | 149 | |
| other | Injection site pain | General disorders | Placebo | 0 | 79 | |
| other | Nasopharyngitis | Infections and infestations | Abaloparatide | 13 | 149 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 79 | |
| other | Bronchitis | Infections and infestations | Abaloparatide | 8 | 149 | |
| other | Bronchitis | Infections and infestations | Placebo | 1 | 79 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abaloparatide | 1 | 149 |
| Total, all-cause mortality | Placebo | 0 | 79 |
| Total, other adverse events | Abaloparatide | 73 | 149 |
| Total, other adverse events | Placebo | 29 | 79 |
| Total, serious adverse events | Abaloparatide | 8 | 149 |
| Total, serious adverse events | Placebo | 4 | 79 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Abaloparatide vs Placebo: Number of Participants With New Clinical Fractures | Trial comparisons |
| Abaloparatide vs Placebo: deaths from any cause | Trial comparisons |
| Abaloparatide vs Placebo: serious adverse events | Trial comparisons |
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/NCT03512262
GET https://conductscience.org/api/trials/v1/NCT03512262/results?page=2