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Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: denosumab (Drug); teriparatide (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Benjamin Z Leder, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Robert M Neer, MD, Principal Investigator, Affiliation: Massachusetts General Hospital


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.

Clinical Details

Official title: The Denosumab And Teriparatide Administration Study (DATA)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bone Mineral Density by Dual X-ray Absorptiometry (DXA)


Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.


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


- 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.

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Related publications:

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.

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. Epub 2003 Sep 20.

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. Epub 2003 Sep 20.

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.

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.

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.

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.

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.

Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J; Amg Bone Loss Study Group. 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):222-9. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26.

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. Epub 2006 Dec 12.

Starting date: June 2009
Last updated: August 28, 2014

Page last updated: August 23, 2015

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