Study of Transitioning From Alendronate to Denosumab

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377819
• Other study ID #: 20050234
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2006
• Last updated: June 30, 2011
• Start date: September 2006
• Est. completion date: July 2008

Study information

• Verified date: June 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaEstonia: State Agency of MedicinesFrance: Ministry of HealthItaly: Ministry of HealthPoland: Drug InstitutPortugal: National Institute of Pharmacy and MedicinesUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: July 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• alendronate
70 mg oral QW
• Denosumab (AMG 162)
60 mg SC q 6 mos

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Total Hip Bone Mineral Density	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.	Baseline, 12 months	No
Secondary	Percent Change From Baseline in Lumbar Spine Bone Mineral Density	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.	Baseline, 12 months	No
Secondary	Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)	Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.	Baseline, 3 months	No

External Links

•   AmgenTrials clinical trials website