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Study Complete
Sponsor ID
20050234

Study of Transitioning from Alendronate to Denosumab

Sponsor ID
20050234
Clinicaltrials.gov ID
NCT00377819
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
504
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent Change From Baseline in Total Hip Bone Mineral Density

Timeframe: Baseline, 12 months

Secondary Outcome Measures

Percent Change From Baseline in Lumbar Spine Bone Mineral Density

Timeframe: Baseline, 12 months

Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)

Timeframe: Baseline, 3 months

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
55+ years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Sep 2006 - Mar 2008
    Inclusion and Exclusion 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