Osteoporosis, Osteoporosis, Postmenopausal
Conditions
Brief summary
In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.
Interventions
DRUGRomosozumab
romosozumab 210 milligrams monthly
DRUGTeriparatide
teriparatide 20 micrograms daily
Sponsors
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women aged 45+ * postmenopausal * osteoporotic with high risk of fracture
Exclusion criteria
* no significant previous use of bone health modifying treatments * known congenital or acquired bone disease other than osteoporosis * significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease * abnormal calcium or parathyroid hormone level * serum vitamin D \<20 ng/dL * anemia (hematocrit \<32%) * history of malignancy (except non-melanoma skin carcinoma) * excessive alcohol use or substance abuse * known contraindications to romosozumab or teriparatide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar spine areal bone mineral density | Month 0 to 12 | Change in lumbar spine bone density between month 0 and month 12 |
Countries
United States
Contacts
CONTACTAparna Patnaik, BA
PRINCIPAL_INVESTIGATORBenjamin Leder, MD
MGH
Outcome results
None listed