Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Osteoporosis Clinical Trial

— DATA  

Official title:

The Denosumab And Teriparatide Administration Study (DATA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926380
• Other study ID #: 20080723
• Secondary ID: 2009P000525
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: December 2016

Study information

• Verified date: May 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• denosumab
denosumab: 60 mg SC every 6 months
• teriparatide
teriparatide: 20 mcg SC QD

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Amgen

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. Epub 2003 Sep 20. — View 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. — View 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. — View 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. Epub 2003 Sep 20. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Spine Bone Density From Baseline to 2 Years		Baseline and 2 years