Clinical trial NCT00542425: Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
Official title: A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: osteoporosis
postmenopausal
bone loss
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 222
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

Detailed description: This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Eligibility criteria: Primary Inclusion Criteria:

* The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have an additional risk factor such as age 65 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by BMD criteria, are also study candidates.
* The patient is in good general health as determined by medical history and physical examination and is without evidence of clinically significant abnormality in the opinion of the Investigator.

Primary Exclusion Criteria:

* History of bone disorders (e.g., Paget's disease) other than postmenopausal osteoporosis.
* Prior treatment with approved or as yet unapproved bone-acting investigational agents.
* History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time.
* History of radiotherapy (radiation therapy).

Primary outcomes:
measure: Change in Marker of Bone Metabolism, PINP
timeFrame: 6 months
measure: Change in Bone Mineral Density, Total Spine.
timeFrame: 6 months
Secondary outcomes:
measure: Change in Bone Mineral Density, Femoral Neck.
timeFrame: 6 months
measure: Change in Bone Mineral Density, Total Hip.
timeFrame: 6 months
measure: Change in Bone Mineral Density, Total Spine.
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Radius Health, Inc.
state: Massachusetts
Study officials:
affiliation: Radius Health, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.