Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Primary Purpose
Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Teriparatide 40-mcg subcutaneous injection
Denosumab Injection
Alendronate Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring osteoporosis, postmenopausal, denosumab, teriparatide, alendronate, Forteo®, Prolia®
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Denosumab 60mg subcutaneous injection
Alendronate 70mg weekly x 8 weeks
Arm Description
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Outcomes
Primary Outcome Measures
Bone Turnover Marker (Blood Sample)
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
Secondary Outcome Measures
Full Information
NCT ID
NCT01750086
First Posted
November 26, 2012
Last Updated
February 22, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01750086
Brief Title
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Official Title
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
osteoporosis, postmenopausal, denosumab, teriparatide, alendronate, Forteo®, Prolia®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Denosumab 60mg subcutaneous injection
Arm Type
Active Comparator
Arm Description
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Arm Title
Alendronate 70mg weekly x 8 weeks
Arm Type
Active Comparator
Arm Description
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Intervention Type
Drug
Intervention Name(s)
Teriparatide 40-mcg subcutaneous injection
Other Intervention Name(s)
Forteo®
Intervention Type
Drug
Intervention Name(s)
Denosumab Injection
Intervention Description
One-time Denosumab injection
Intervention Type
Drug
Intervention Name(s)
Alendronate Oral Tablet
Intervention Description
weekly alendronate for 8 weeks
Primary Outcome Measure Information:
Title
Bone Turnover Marker (Blood Sample)
Description
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20814967
Citation
Cosman F, Eriksen EF, Recknor C, Miller PD, Guanabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):503-11. doi: 10.1002/jbmr.238.
Results Reference
background
PubMed Identifier
14500805
Citation
Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20.
Results Reference
background
PubMed Identifier
16093465
Citation
Cosman F, Nieves J, Zion M, Woelfert L, Luckey M, Lindsay R. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med. 2005 Aug 11;353(6):566-75. doi: 10.1056/NEJMoa050157.
Results Reference
background
PubMed Identifier
11564687
Citation
Kostenuik PJ, Capparelli C, Morony S, Adamu S, Shimamoto G, Shen V, Lacey DL, Dunstan CR. OPG and PTH-(1-34) have additive effects on bone density and mechanical strength in osteopenic ovariectomized rats. Endocrinology. 2001 Oct;142(10):4295-304. doi: 10.1210/endo.142.10.8437.
Results Reference
background
PubMed Identifier
20164296
Citation
Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab. 2010 Apr;95(4):1838-45. doi: 10.1210/jc.2009-1703. Epub 2010 Feb 17.
Results Reference
background
PubMed Identifier
25933031
Citation
Tsai JN, Zhu Y, Foley K, Lee H, Burnett-Bowie SA, Neer RM, Leder BZ. Comparative Resistance to Teriparatide-Induced Bone Resorption With Denosumab or Alendronate. J Clin Endocrinol Metab. 2015 Jul;100(7):2718-23. doi: 10.1210/jc.2015-1541. Epub 2015 May 1.
Results Reference
derived
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Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
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