Osteoporosis in postmenopausal women MedDRA version: 14.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: BA058 Drug Product for Injection (Cartridge)
Product Code: BA058
Pharmaceutical Form: Injection
INN or Proposed INN: BA058
Current Sponsor code: BA058
Other descriptive name: [Glu22,25,
Sponsors
Radius Health, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 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 o 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, ECG and medical history, with a body mass index (BMI) of 18.5 to 33 • Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 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) • History of radiotherapy - other than radioiodine • 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 nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time • History of thyroid disorders, 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 PTH or PTHrP • Prior treatment with bone acting drugs within the past five years • Prior treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months • Prior treatment with an investigational drug within the past 12 months • Hepatitis B, Hepatitis C, HIV-1 or HIV-2 positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the comparative safety and efficacy of 18 months of treatment with BA058 80 µg on reduction of vertebral fracture incidence in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis when compared with Placebo.;Secondary Objective: Determine the comparative efficacy of 18 months of BA058 80 µg treatment in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis: • on lumbar spine, hip, and femoral neck bone mineral density when compared to teriparatide • on reduction of non-vertebral fracture incidence when compared with placebo Determine the overall safety and tolerability of 18 months of BA058 80 µg treatment in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis: • specifically with respect to number of hypercalcemic events when compared to teriparatide and placebo Provide additional evidence of safety through: • bone histomorphometric assessment of bone biopsy samples in a subset of patients in the BA058 80 µg, placebo and Teriparatide groups. • renal radiological assessment by renal CT scan in a subset of patients from selected centers in the BA058 80 µg, placebo and teriparatide groups ;Primary end point(s): Number of BA058-treated patients showing new vertebral fractures at End-of-Treatment when compared to Placebo.;Timepoint(s) of evaluation of this end point: Baseline and at the end-of-trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determine the comparative efficacy of 18 months of BA058 80 µg treatment in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis: • on lumbar spine, hip, and femoral neck bone mineral density when compared to teriparatide • on reduction of non-vertebral fracture incidence when compared with placebo Determine the overall safety and tolerability of 18 months of BA058 80 µg treatment in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis: • specifically with respect to number of hypercalcemic events when compared to teriparatide and placebo Provide additional evidence of safety through: • bone histomorphometric assessment of bone biopsy samples in a subset of patients in the BA058 80 µg, placebo and Teriparatide groups • renal radiological assessment by renal CT scan in a subset of patients from selected centers in the BA058 80 µg, placebo and teriparatide groups;Timepoint(s) of evaluation of this end point: Screening, pre-treatment, baseline, months 1, 3, 6, 9, 12, 15, 18, 19 | — |
Countries
Argentina, Brazil, Czech Republic, Denmark, Estonia, Hong Kong, India, Lithuania, Poland, Romania, United States
Contacts
Public ContactClinical Trial Leader
Nordic Clinical Development AS
Outcome results
None listed