Clinical trial NCT01750086: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Keywords: osteoporosis
postmenopausal
denosumab
teriparatide
alendronate
Forteo®
Prolia®
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 27
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.


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

Primary outcomes:
measure: Bone Turnover Marker (Blood Sample)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
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.
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.
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.
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.
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.
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.