Trial · NCT02089997
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to Month 12 | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment. |
| Secondary | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Radius BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Change From Baseline in Height | Baseline and final assessment (up to Month 12) | |
| Secondary | Number of Participants Who Had Lumbar Backache at Final Assessment | Final assessment (Month 12) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02089997/registered