Denosumab and Teriparatide Study (DATA-2)
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: denosumab (Drug); teriparatide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Benjamin Leder, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact: Joy Tsai, MD, Phone: 617-726-4650
Summary
The aim of the study is to assess the effect of an antiresorptive medication in combination
with standard dose or alternate dose teriparatide.
Clinical Details
Official title: Denosumab and Teriparatide Study (DATA-2)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
Exclusion Criteria:
- no significant previous use of bone health modifying treatments
Locations and Contacts
Joy Tsai, MD, Phone: 617-726-4650
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting Paul Wallace, Phone: 617-726-6129
Additional Information
Starting date: August 2014
Last updated: February 2, 2015
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