Clinical trial NCT00100620: Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Official title: Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Corticosteroid induced osteoporosis
prevention
treatment
zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-04
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.


Eligibility criteria: Inclusion Criteria:

* Long duration treatment with corticosteroids (started or ongoing)

Exclusion Criteria:

* History of osteogenesis imperfecta, multiple myeloma or Paget's disease
* History of Hyperparathyroidism, hyperthyroidism
* History of Osteomalacia

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
Secondary outcomes:
measure: Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline
measure: Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline
measure: Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12
measure: Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders
state: Alabama
city: Gainesville
country: United States
facility: United Osteoporosis Centers
state: Georgia
city: Cumberland
country: United States
facility: Osteoporosis & Clinical Trials
state: Maryland
city: Columbus
country: United States
facility: University of Ohio
state: Ohio
city: Wyomissing
country: United States
facility: Radiant Research
state: Pennsylvania
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
Study officials:
References:
citation: Devogelaer JP, Sambrook P, Reid DM, Goemaere S, Ish-Shalom S, Collette J, Su G, Bucci-Rechtweg C, Papanastasiou P, Reginster JY. Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids. Rheumatology (Oxford). 2013 Jun;52(6):1058-69. doi: 10.1093/rheumatology/kes410. Epub 2013 Jan 30.
citation: Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.
citation: Reid DM, Devogelaer JP, Saag K, Roux C, Lau CS, Reginster JY, Papanastasiou P, Ferreira A, Hartl F, Fashola T, Mesenbrink P, Sambrook PN; HORIZON investigators. Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2009 Apr 11;373(9671):1253-63. doi: 10.1016/S0140-6736(09)60250-6.