Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Post Menopausal Osteoporosis

In brief

To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.

Key facts

Study ID

NCT01674621

Run by

Radius Health, Inc.

People needed

250

Starts

2012-09-25

Expected to finish

2013-08-02

Last updated by the study team

2020-06-16

Who can join

Age: any, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal woman, less than 85 years old.
• BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years).
• Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.
• Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.

You may not qualify if…

• BMD T-score ≤-5.0 at the lumbar spine or hip.
• History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
• Significantly impaired renal function.
• History of any cancer.

Where it is running

• Study site — Lakewood, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Bethesda, Maryland, United States
• Study site — Aalborg, Denmark
• Study site — Ballerup Municipality, Denmark
• Study site — Vejle, Denmark
• Study site — Tallinn, Estonia
• Study site — Lodz, Poland
• Study site — Warsaw, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.