Status:
COMPLETED
Study of Transitioning From Alendronate to Denosumab
Lead Sponsor:
Amgen
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
55+ years
Phase:
PHASE3
Brief 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 ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT00377819
Start Date
September 1 2006
End Date
July 1 2008
Last Update
July 11 2011
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