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Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01750086
First received: November 26, 2012
Last updated: August 28, 2014
Last verified: August 2014

November 26, 2012
August 28, 2014
January 2013
December 2014   (final data collection date for primary outcome measure)
Bone turnover marker (blood sample) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01750086 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Postmenopausal Osteoporosis
Drug: Teriparatide 40-mcg subcutaneous injection
Other Name: Forteo®
  • Active Comparator: Denosumab 60mg subcutaneous injection
    Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
    Intervention: Drug: Teriparatide 40-mcg subcutaneous injection
  • Active Comparator: Alendronate 70mg weekly x 8 weeks
    Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
    Intervention: Drug: Teriparatide 40-mcg subcutaneous injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
45 Years and older
Yes
Contact: Benjamin Z Leder, MD 617-724-2039 bzleder@partners.org
Contact: Joy N Tsai, MD 6177264650 jntsai@partners.org
United States
 
NCT01750086
2012P001956
Yes
Benjamin Leder, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP