Phase 3 Completed N=504 Randomized Quadruple-blind Treatment

Study of Transitioning From Alendronate to Denosumab

Postmenopausal Osteoporosis

Source: ClinicalTrials.gov NCT00377819 ↗

Enrolled (actual)

504

Serious AEs

6.2%

Results posted

Aug 2010

Primary outcomePrimary: Percent Change From Baseline in Total Hip Bone Mineral Density — 1.05; 1.9 Percent Change — p=<0.0001

Summary

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Total Hip Bone Mineral Density	1.05; 1.9	<0.0001 sig
SECONDARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density	1.85; 3.03	<0.0001 sig
SECONDARY Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)	-4.2; -63.3	<0.0001 sig

Eligibility Criteria

Inclusion Criteria

Postmenopausal females 55 yrs or older
Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4

Exclusion Criteria

Vitamin D deficiency
Administration of intravenous bisphosphonate, or
fluoride (except for dental treatment) or
strontium ranelate
Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00377819). 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.