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

Condition Intervention Phase
Postmenopausal Osteoporosis Drug: Teriparatide 40-mcg subcutaneous injection Drug: Denosumab Injection Drug: Alendronate Oral Tablet Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Resource links provided by NLM:


Further study details as provided by Benjamin Leder, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 27
Study Start Date: January 2013
Study Completion Date: August 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Denosumab 60mg subcutaneous injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection
Other Name: Forteo®
Drug: Denosumab Injection
One-time Denosumab injection
Active Comparator: Alendronate 70mg weekly x 8 weeks
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection
Other Name: Forteo®
Drug: Alendronate Oral Tablet
weekly alendronate for 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750086


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01750086     History of Changes
Other Study ID Numbers: 2012P001956
First Submitted: November 26, 2012
First Posted: December 17, 2012
Results First Submitted: November 30, 2016
Results First Posted: January 26, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017

Keywords provided by Benjamin Leder, MD, Massachusetts General Hospital:
osteoporosis
postmenopausal
denosumab
teriparatide
alendronate
Forteo®
Prolia®

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Resorption
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Alendronate
Teriparatide
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs