Phase 2 Study of AMG 785 in Postmenopausal Women With Low Bone Mineral Density - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00896532

Purpose

This phase 2 clinical trial will study the safety and efficacy of AMG 785, an investigational bone building agent, in the treatment of postmenopausal women with low bone mineral density. Different doses and dosing frequencies of AMG 785 will be compared to placebo in a double-blind fashion. In addition, AMG 785 will be compared to open label alendronate and open label teriparatide.

The clinical hypothesis is that AMG 785 compared with placebo will cause a greater percent change from baseline in lumbar spine bone mineral density.

Condition	Intervention	Phase
Low Bone Mineral Density Postmenopausal Osteoporosis	Drug: Active Comparator Alendronate Drug: Placebo Drug: AMG 785 Drug: Active comparator teriparatide	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate Alendronate sodium

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Percent change from baseline at month 12 in bone mineral density at the lumbar spine for the individual AMG 785 groups and pooled placebo arms. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline at month 12 in bone mineral density at the total hip, femoral neck and distal radius for the individual AMG 785 groups and pooled placebo arms. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percent change from baseline at month 1, 3, 6, 9 and 12 in bone turnover markers for the individual AMG 785 groups and pooled placebo arms. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Nature, frequency, severity of adverse events & their relationship to treatment; Changes from baseline in vital signs, laboratory assessments, ECG parameters; Bone histologic & histomorphometric pameters; Formation of anti-AMG 785 antibodies [ Time Frame: 28 months ] [ Designated as safety issue: Yes ]
Percent change from baseline at month 24 in bone mineral density for the individual AMG 785 groups and pooled placebo arms. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Percent change from baseline in Quantitative Computed Tomography (QCT) BMD & variables for AMG 785 and teriparatide groups during the first year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percent change from baseline at month 6 in bone mineral density at the lumbar spine, total hip and femoral neck for the individual AMG 785 groups and pooled placebo arms. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	419
Study Start Date:	June 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A AMG 785 70mg or 140mg or 210mg SC or placebo SC every month (QM)	Drug: AMG 785 140mg SC QM Drug: Placebo SC QM Drug: AMG 785 210mg SC QM Drug: AMG 785 70mg SC QM
Active Comparator: E Teriparatide 20ug SC every day (QD)	Drug: Active comparator teriparatide 20µg SC every day (QD)
Experimental: B AMG 785 140mg or 210mg SC or placebo SC every three months (Q3M)	Drug: Placebo SC Q3M Drug: AMG 785 140mg SC Q3M Drug: AMG 785 210mg SC Q3M
Active Comparator: D Alendronate (Fosamax) 70mg PO every week (QW)	Drug: Active Comparator Alendronate 70mg PO every week (QW)

Eligibility

Ages Eligible for Study:	55 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ambulatory, postmenopausal women, aged ≥ 55 to ≤ 85
Low BMD measured by Dual energy X-ray Absorptiometry (DXA) and assessed by the central imaging vendor (equivalent to T-scores between -2.0 and -3.5)

Exclusion Criteria:

History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50
Untreated hyper- or hypothyroidism
Current hyper- or hypoparathyroidism, hypo- or hypercalcemia
Elevated transaminases
Significantly impaired renal function
Positive for: HIV, Hep-C or Hep-B surface antigen
Malignancy
History of solid organ or bone marrow transplants
Use of agents affecting bone metabolism
Contraindicated or intolerant of alendronate therapy
Contraindicated or intolerant of teriparatide therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896532

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00896532 History of Changes
Other Study ID Numbers:	20060326
Study First Received:	May 7, 2009
Last Updated:	January 20, 2011
Health Authority:	Argentina: Ministry of Health Austria: Central Ethics Committee Austria: Federal Ministry for Health and Women Belgium: Ministry of Health Canada: Health Canada Denmark: Central Ethics Committee Denmark: Danish Medicines Agency Spain: reference Ethics Committee Spain: Spanish Agency of Medicines United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Alendronate
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012