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Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750086
First Posted: December 17, 2012
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
November 26, 2012
December 17, 2012
November 30, 2016
January 26, 2017
March 27, 2017
January 2013
April 2014   (Final data collection date for primary outcome measure)
Bone Turnover Marker (Blood Sample) [ Time Frame: 8 weeks ]
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
Bone Turnover Marker (Blood Sample) [ Time Frame: Up to 2 years ]
Complete list of historical versions of study NCT01750086 on ClinicalTrials.gov Archive Site
Not Provided
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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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postmenopausal Osteoporosis
  • Drug: Teriparatide 40-mcg subcutaneous injection
    Other Name: Forteo®
  • Drug: Denosumab Injection
    One-time Denosumab injection
  • Drug: Alendronate Oral Tablet
    weekly alendronate for 8 weeks
  • Active Comparator: Denosumab 60mg subcutaneous injection
    Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
    Interventions:
    • Drug: Teriparatide 40-mcg subcutaneous injection
    • Drug: Denosumab Injection
  • Active Comparator: Alendronate 70mg weekly x 8 weeks
    Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
    Interventions:
    • Drug: Teriparatide 40-mcg subcutaneous injection
    • Drug: Alendronate Oral Tablet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2014
April 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
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01750086
2012P001956
Yes
Not Provided
Not Provided
Benjamin Leder, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
February 2017

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