Back to resultsDenosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis (DATA)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
denosumab
teriparatide
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, postmenopausal, denosumab, teriparatide, Forteo®, DXA, Bone Mineral Density, pQCT
Eligibility Criteria
Inclusion Criteria:
Must satisfy A and B and C and D below:
- (A) Women aged > 55
- (B) Postmenopausal
- (C) Osteoporotic with high risk of fracture
Exclusion Criteria:
- Confirmed serum alkaline phosphatase above upper normal limit with no explanation
- Liver disease (AST or ALT > 2 x upper normal limit).
- Renal disease (serum creatinine > 2.0 mg/dl).
- Hypercalcemia (Ca >10.5 mg/dL)
- Elevated blood PTH (intact PTH > 65 pg/ml)
- Serum 25-OH vitamin D < 20 ng/ml
- HCT < 32%.
- History of malignancy (except basal cell carcinoma) or radiation therapy.
- Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures.
- Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease)
- Current use or use in the past 6 months of oral bisphosphonate
- Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
- Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months.
- Any current or previous use of strontium or any parenteral bisphosphonate.
- Known sensitivity to mammalian cell-derived drug products.
- Known sensitivity to teriparatide or any of its excipients.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
denosumab ONLY
teriparatide (Forteo®) ONLY
denosumab and teriparatide (Forteo®)
Arm Description
Outcomes
Primary Outcome Measures
Change in Spine Bone Density From Baseline to 2 Years
Secondary Outcome Measures
Full Information
NCT ID
NCT00926380
First Posted
June 19, 2009
Last Updated
May 30, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT00926380
Brief Title
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Acronym
DATA
Official Title
The Denosumab And Teriparatide Administration Study (DATA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, postmenopausal, denosumab, teriparatide, Forteo®, DXA, Bone Mineral Density, pQCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
denosumab ONLY
Arm Type
Experimental
Arm Title
teriparatide (Forteo®) ONLY
Arm Type
Experimental
Arm Title
denosumab and teriparatide (Forteo®)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
denosumab
Intervention Description
denosumab: 60 mg SC every 6 months
Intervention Type
Drug
Intervention Name(s)
teriparatide
Other Intervention Name(s)
Forteo®
Intervention Description
teriparatide: 20 mcg SC QD
Primary Outcome Measure Information:
Title
Change in Spine Bone Density From Baseline to 2 Years
Time Frame
Baseline and 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must satisfy A and B and C and D below:
(A) Women aged > 55
(B) Postmenopausal
(C) Osteoporotic with high risk of fracture
Exclusion Criteria:
Confirmed serum alkaline phosphatase above upper normal limit with no explanation
Liver disease (AST or ALT > 2 x upper normal limit).
Renal disease (serum creatinine > 2.0 mg/dl).
Hypercalcemia (Ca >10.5 mg/dL)
Elevated blood PTH (intact PTH > 65 pg/ml)
Serum 25-OH vitamin D < 20 ng/ml
HCT < 32%.
History of malignancy (except basal cell carcinoma) or radiation therapy.
Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures.
Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease)
Current use or use in the past 6 months of oral bisphosphonate
Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months.
Any current or previous use of strontium or any parenteral bisphosphonate.
Known sensitivity to mammalian cell-derived drug products.
Known sensitivity to teriparatide or any of its excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Z Leder, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert M Neer, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
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
11346808
Citation
Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001 May 10;344(19):1434-41. doi: 10.1056/NEJM200105103441904.
Results Reference
background
PubMed Identifier
14500804
Citation
Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ; PaTH Study Investigators. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1207-15. doi: 10.1056/NEJMoa031975. Epub 2003 Sep 20.
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
11341338
Citation
Cosman F, Nieves J, Woelfert L, Formica C, Gordon S, Shen V, Lindsay R. Parathyroid hormone added to established hormone therapy: effects on vertebral fracture and maintenance of bone mass after parathyroid hormone withdrawal. J Bone Miner Res. 2001 May;16(5):925-31. doi: 10.1359/jbmr.2001.16.5.925.
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
9568710
Citation
Lacey DL, Timms E, Tan HL, Kelley MJ, Dunstan CR, Burgess T, Elliott R, Colombero A, Elliott G, Scully S, Hsu H, Sullivan J, Hawkins N, Davy E, Capparelli C, Eli A, Qian YX, Kaufman S, Sarosi I, Shalhoub V, Senaldi G, Guo J, Delaney J, Boyle WJ. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell. 1998 Apr 17;93(2):165-76. doi: 10.1016/s0092-8674(00)81569-x.
Results Reference
background
PubMed Identifier
9520411
Citation
Yasuda H, Shima N, Nakagawa N, Yamaguchi K, Kinosaki M, Mochizuki S, Tomoyasu A, Yano K, Goto M, Murakami A, Tsuda E, Morinaga T, Higashio K, Udagawa N, Takahashi N, Suda T. Osteoclast differentiation factor is a ligand for osteoprotegerin/osteoclastogenesis-inhibitory factor and is identical to TRANCE/RANKL. Proc Natl Acad Sci U S A. 1998 Mar 31;95(7):3597-602. doi: 10.1073/pnas.95.7.3597.
Results Reference
background
PubMed Identifier
18381571
Citation
Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.
Results Reference
background
PubMed Identifier
18539106
Citation
Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008 Aug;43(2):222-229. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26.
Results Reference
background
PubMed Identifier
17164314
Citation
Antoniucci DM, Sellmeyer DE, Bilezikian JP, Palermo L, Ensrud KE, Greenspan SL, Black DM. Elevations in serum and urinary calcium with parathyroid hormone (1-84) with and without alendronate for osteoporosis. J Clin Endocrinol Metab. 2007 Mar;92(3):942-7. doi: 10.1210/jc.2006-1788. Epub 2006 Dec 12.
Results Reference
background
PubMed Identifier
26964731
Citation
Tsai JN, Uihlein AV, Burnett-Bowie SM, Neer RM, Derrico NP, Lee H, Bouxsein ML, Leder BZ. Effects of Two Years of Teriparatide, Denosumab, or Both on Bone Microarchitecture and Strength (DATA-HRpQCT study). J Clin Endocrinol Metab. 2016 May;101(5):2023-30. doi: 10.1210/jc.2016-1160. Epub 2016 Mar 10.
Results Reference
derived
PubMed Identifier
26144908
Citation
Leder BZ, Tsai JN, Uihlein AV, Wallace PM, Lee H, Neer RM, Burnett-Bowie SA. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial. Lancet. 2015 Sep 19;386(9999):1147-55. doi: 10.1016/S0140-6736(15)61120-5. Epub 2015 Jul 2.
Results Reference
derived
PubMed Identifier
24420643
Citation
Yu EW, Kumbhani R, Siwila-Sackman E, DeLelys M, Preffer FI, Leder BZ, Wu JY. Teriparatide (PTH 1-34) treatment increases peripheral hematopoietic stem cells in postmenopausal women. J Bone Miner Res. 2014 Jun;29(6):1380-6. doi: 10.1002/jbmr.2171.
Results Reference
derived
PubMed Identifier
23683600
Citation
Tsai JN, Uihlein AV, Lee H, Kumbhani R, Siwila-Sackman E, McKay EA, Burnett-Bowie SA, Neer RM, Leder BZ. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. Lancet. 2013 Jul 6;382(9886):50-6. doi: 10.1016/S0140-6736(13)60856-9. Epub 2013 May 15.
Results Reference
derived
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Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
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