Study to Evaluate the Safety and Efficacy of BA058 for Prevention of Fracture in Postmenopausal Women - Full Text View

Purpose

The purpose of this study is to determine whether BA058, a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Condition	Intervention	Phase
Osteoporosis Postmenopausal Osteoporosis	Drug: Placebo Drug: BA058 80 mcg Drug: teriparatide	Phase 3

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 Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:

New vertebral fractures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Number of BA058-treated patients showing new vertebral fractures by X-ray at End-of-Treatment when compared to Placebo in postmenopausal women

Secondary Outcome Measures:

Bone mineral density of lumbar spine, hip, and femoral neck [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Efficacy of BA058 on lumbar spine, hip, and femoral neck bone mineral density at End-of-Treatment when compared to teriparatide in postmenopausal women
Non-vertebral fractures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Efficacy of BA058 on incidence of non-vertebral fractures at End-of-Treatment when compared to Placebo in postmenopausal women
Number of hypercalcemic events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Number of hypercalcemic events in BA058 treated patients at End-of-Treatment when compared to teriparatide in postmenopausal women

Estimated Enrollment:	2400
Study Start Date:	April 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo identical in appearance to BA058 study drug	Drug: Placebo Placebo 0 mcg subcutaneous daily
Experimental: BA058 80 mcg	Drug: BA058 80 mcg BA058 80 mcg subcutaneous daily
Active Comparator: teriparatide Blinded until after randomization, then open-label	Drug: teriparatide teriparatide 20 mcg subcutaneous daily Other Names: Forteo Forsteo

Detailed Description:

This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
The women are to have a bone mineral density (BMD) T score ≤ 2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ 2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤-3.0 and > -5.0
Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Exclusion Criteria:

History of more than 4 mild or moderate spine fractures or any severe fracture
Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
Prior treatment with an investigational drug within the past 12 months
History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343004

Show 28 Study Locations

Sponsors and Collaborators

Radius Health, Inc.

Investigators

Study Director:

Louis Brenner, MD

Radius Health, Inc.

More Information

No publications provided

Responsible Party:	Radius Health, Inc.
ClinicalTrials.gov Identifier:	NCT01343004 History of Changes
Other Study ID Numbers:	BA058-05-003
Study First Received:	April 26, 2011
Last Updated:	March 21, 2013
Health Authority:	Argentina: Ministry of Health Brazil: Ministry of Health Hong Kong: Department of Health Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Estonia: The State Agency of Medicine Lithuania: State Medicine Control Agency - Ministry of Health Poland: Ministry of Health Romania: National Medicines Agency United States: Food and Drug Administration

Keywords provided by Radius Health, Inc.:

osteoporosis
postmenopausal
bone loss

Additional relevant MeSH terms:

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

Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013