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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


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 Density

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


Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.


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


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

Page last updated: August 23, 2015

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