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Phase 2 Dose-Finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
This study is ongoing, but not recruiting participants.
Sponsored by: Radius Health
Information provided by: Radius Health
ClinicalTrials.gov Identifier: NCT00542425
  Purpose

The purpose of this study is to determine whether BA058, a modified version of the natural hormone PTHrP (parathyroid hormone-related peptide) which is important in bone formation, is effective in building bone in postmenopausal women with osteoporosis and to choose the optimal dose to bring forward into Phase 3 development.


Condition Intervention Phase
Osteoporosis
Drug: BA058
Drug: PTH
Drug: Placebo
Phase II

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Radius Health:

Primary Outcome Measures:
  • Change in markers of bone metabolism. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in bone mineral density. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 225
Study Start Date: April 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: Placebo
0 ug subcutaneous Daily for 6 months
2: Experimental Drug: BA058
20 ug, 40 ug, or 80 ug subcutaneous Daily for 6 months
3: Experimental Drug: BA058
20 ug, 40 ug, or 80 ug subcutaneous Daily for 6 months
4: Experimental Drug: BA058
20 ug, 40 ug, or 80 ug subcutaneous Daily for 6 months
5: Active Comparator Drug: PTH
20 ug subcutaneous Daily for 6 months

Detailed Description:

Many of the drugs prescribed for osteoporosis work by preventing further bone loss. Parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) have both been shown to promote bone growth in humans when given in an intermittent manner. This study will evaluate the ability of BA058, a modified version of the natural hormone PTHrP, to promote bone growth in postmenopausal women with osteoporosis.

The study encompasses 24 weeks of treatment. Participants will be randomly assigned to receive BA058, a placebo, or an approved PTH medication by subcutaneous injection, one time per day. There will be 13 study visits, including a screening visit, two pretreatment visits, nine treatment visits, and a follow-up visit. Participants will be asked to take a Calcium and Vitamin D supplement throughout the study. Medical history, a physical exam, vital signs, ECGs, blood and urine collections, and scans to measure bone density will occur at selected visits.

  Eligibility

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

Primary Inclusion Criteria:

  • The patient is a healthy ambulatory postmenopausal woman from 55 to 85 years of age (inclusive) with osteoporosis. Postmenopausal women younger than 55 years of age with known osteoporosis who meet all other entry criteria also may be considered for enrollment.
  • The patient has been postmenopausal for at least 5 years. Postmenopausal status will be established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value.
  • 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 (including vital signs), has a body mass index (BMI) of 18.5 to 33, inclusive, 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.
  • History of radiotherapy (radiation therapy).
  • History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time.
  • Vitamin D deficiency.
  • Patients known to be Hepatitis B, Hepatitis C, HIV-1 or HIV-2 positive.
  • Patients who have undergone bilateral hip replacement (unilateral hip replacement is acceptable).
  • Known history of hypersensitivity to any of the test materials or related compounds.
  • Prior treatment with bisphosphonates or strontium in the past five years, or prior treatment with parathyroid hormone or its analogs, with fluoride, or with gallium nitrate, or with as yet unapproved bone-acting investigational agents such as denosumab at any time.
  • Prior treatment with calcitonin, estrogens, estrogen derivatives, SERMs (such as raloxifene or tamoxifen), tibolone, progestins or anabolic steroids in the past 6 months or current treatment with thiazide diuretics.
  • Daily treatment with oral, intranasal or inhaled corticosteroids within the 6 months prior to the Screening Period.
  • Exposure to general anesthesia within the 12 weeks prior to the Screening Period.
  • Exposure to an investigational drug within the 12 months prior to the Screening Period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542425

Locations
United States, Massachusetts
Radius Health, Inc.
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Radius Health
Investigators
Study Director: Louis St.L. O'Dea, MB BCh BAO. FRCP(C) Radius Health, Inc.
  More Information

Responsible Party: Radius Health, Inc. ( Jonathan Guerriero, Program Director )
Study ID Numbers: BA058-05-002
Study First Received: October 10, 2007
Last Updated: March 7, 2008
ClinicalTrials.gov Identifier: NCT00542425  
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   India: Ministry of Health

Keywords provided by Radius Health:
osteoporosis
postmenopausal
bone loss

Study placed in the following topic categories:
Signs and Symptoms
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 15, 2009