Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
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ClinicalTrials.gov Identifier: NCT01750086 |
Recruitment Status :
Completed
First Posted : December 17, 2012
Results First Posted : December 1, 2016
Last Update Posted : March 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopausal Osteoporosis | Drug: Teriparatide 40-mcg subcutaneous injection Drug: Denosumab Injection Drug: Alendronate Oral Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
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 |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Denosumab 60mg subcutaneous injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
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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.
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Drug: Teriparatide 40-mcg subcutaneous injection
Other Name: Forteo® Drug: Alendronate Oral Tablet weekly alendronate for 8 weeks |
- 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.

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
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 |
Other Study ID Numbers: |
2012P001956 |
First Posted: | December 17, 2012 Key Record Dates |
Results First Posted: | December 1, 2016 |
Last Update Posted: | March 27, 2017 |
Last Verified: | February 2017 |
osteoporosis postmenopausal denosumab teriparatide |
alendronate Forteo® Prolia® |
Osteoporosis Osteoporosis, Postmenopausal Bone Resorption Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |
Denosumab Alendronate Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs Calcium-Regulating Hormones and Agents |