Postmenopausal Osteoporosis | Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Postmenopausal Osteoporosis research study
What is the primary objective of this study?
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
Who is eligible to participate?
Inclusion Criteria: Must satisfy A and B and C below: A. Women aged 45+ B. Postmenopausal C. Osteoporotic with high risk of fracture Exclusion Criteria: - History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system - Current alcohol or substance abuse - Major psychiatric disorders - Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia - Known congenital or acquired bone disease other than osteoporosis - Current use or past use in the past 12 months of oral bisphosphonates - Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin - Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months - Any current or previous use of strontium or intravenous bisphosphonates - Sensitivity to cell-derived drug products or teriparatide - Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months - Inability to sit upright for 30 minutes - Esophageal abnormalities
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Teriparatide 40-mcg subcutaneous injection
Drug:Denosumab InjectionOne-time Denosumab injection
Drug:Alendronate Oral Tabletweekly alendronate for 8 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Denosumab 60mg subcutaneous injectionEach subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Alendronate 70mg weekly x 8 weeksEach subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Start Date: January 2013
Completed Date: August 2014
Phase: Phase 4
Primary Outcome: Bone Turnover Marker (Blood Sample)
Study sponsors, principal investigator, and references
Lead Sponsor: Massachusetts General Hospital
Cosman F, Eriksen EF, Recknor C, Miller PD, Guañabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):503-11. doi: 10.1002/jbmr.238.