Phase 4
N=27
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01750086 ↗Enrolled (actual)
27
Serious AEs
8.0%
Results posted
Dec 2016
Primary outcome: Primary: Bone Turnover Marker (Blood Sample) — -7; 43 percentage of change in CTX
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Teriparatide 40-mcg subcutaneous injection (Drug); Denosumab Injection (Drug); Alendronate Oral Tablet (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Turnover Marker (Blood Sample) |
-7; 43 | — |
Summary
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01750086). 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.