Study of Transitioning From Alendronate to Denosumab
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: alendronate (Drug); Denosumab (AMG 162) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
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.
Clinical Details
Official title: A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percent Change From Baseline in Total Hip Bone Mineral Density
Secondary outcome: Percent Change From Baseline in Lumbar Spine Bone Mineral DensityPercent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Notice regarding posted summaries of trial results AmgenTrials clinical trials website
Starting date: September 2006
Last updated: June 30, 2011
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