Phase 2
N=94
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00926380 ↗Enrolled (actual)
94
Serious AEs
4.3%
Results posted
May 2018
Primary outcome: Primary: Change in Spine Bone Density From Baseline to 2 Years — 8.3; 9.5; 12.9 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- denosumab (Drug); teriparatide (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Spine Bone Density From Baseline to 2 Years |
8.3; 9.5; 12.9 | — |
Summary
The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.
Eligibility Criteria
Inclusion Criteria
Must satisfy A and B and C and D below:
- (A) Women aged > 55
- (B) Postmenopausal
- (C) Osteoporotic with high risk of fracture
Exclusion Criteria
- Confirmed serum alkaline phosphatase above upper normal limit with no explanation
- Liver disease (AST or ALT > 2 x upper normal limit).
- Renal disease (serum creatinine > 2.0 mg/dl).
- Hypercalcemia (Ca >10.5 mg/dL)
- Elevated blood PTH (intact PTH > 65 pg/ml)
- Serum 25-OH vitamin D < 20 ng/ml
- HCT < 32%.
- History of malignancy (except basal cell carcinoma) or radiation therapy.
- Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures.
- Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease)
- Current use or use in the past 6 months of oral bisphosphonate
- Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
- Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months.
- Any current or previous use of strontium or any parenteral bisphosphonate.
- Known sensitivity to mammalian cell-derived drug products.
- Known sensitivity to teriparatide or any of its excipients.
Data sourced from ClinicalTrials.gov (NCT00926380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.