Phase 4
Completed N=224
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
Source: ClinicalTrials.gov NCT00887354 ↗Enrolled (actual)
224
Serious AEs
22.2%
Results posted
Jan 2017
Primary outcomePrimary: Change in Lumbar Spine Areal Bone Mineral Density (BMD) — 0.094; 0.055 gram per square centimeter (g/cm^2) — p=<.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lumbar Spine Areal Bone Mineral Density (BMD) |
0.094; 0.055 | <.0001 sig |
| SECONDARY Change in Lumbar Spine Areal Bone Mineral Density |
0.053; 0.032; 0.078; 0.044 | — |
| SECONDARY Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb |
-0.001; -0.001; 0.001; -0.001; 0.007; 0.005 | — |
| SECONDARY Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire |
7.37; 5.10; 11.32; 11.09; 14.37; 12.81 | — |
| SECONDARY Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale |
9.4; 8.2; 4.7; 12.9; 23.5; 20.0 | — |
| SECONDARY Visual Analog Scale (VAS) |
16.44; 23.54; 9.28; 19.24; 6.90; 18.19 | — |
| SECONDARY Timed "Up and Go" Test |
26.45; 32.38; 20.13; 24.48; 17.75; 21.14 | — |
Eligibility Criteria
Inclusion Criteria
- Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region
- Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men
Exclusion Criteria
- Clinically significant abnormal laboratory values
- History of unresolved skeletal diseases that affect bone metabolism
- Polytrauma participants and participants with fractures at more than one site
Data sourced from ClinicalTrials.gov (NCT00887354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.