Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01750086
First received: November 26, 2012
Last updated: February 22, 2017
Last verified: February 2017
  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: No masking
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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 26, 2012
Results First Received: November 30, 2016
Last Updated: February 22, 2017

Keywords provided by 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
Denosumab
Alendronate
Diphosphonates
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017