Phase 3
Completed N=394
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT02157948 ↗Enrolled (actual)
394
Serious AEs
4.9%
Results posted
Aug 2017
Primary outcomePrimary: Percent Change From Baseline in Lumbar Spine BMD — 5.78; 5.73 percent change — p=< 0.001
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine BMD |
5.78; 5.73 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX) |
-86.39; -88.05; -76.46; -79.48; -71.34; -75.44 | — |
| SECONDARY Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) |
-29.59; -29.86; -76.63; -77.74; -71.44; -72.08 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has provided informed consent prior to any study-specific activities/procedures
- Ambulatory postmenopausal women.
- Age 55 years or older
- Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.
Exclusion Criteria
- Administration of osteoporosis treatments or bone active treatments within specific timeframes
- Vitamin D deficiency
- Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
- Contraindications to denosumab therapy (e.g., hypocalcemia)
Data sourced from ClinicalTrials.gov (NCT02157948). 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.