Clinical trial NCT00132808: Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Official title: A 2-year Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Administered Either Annually at Randomization and 12 Months, or Administered at Randomization Only in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteopenia
Keywords: Postmenopausal osteoporosis
osteopenia
zoledronic acid
Osteopenia (osteoporosis prevention)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 581
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* Greater than or equal to 45 years of age
* Osteopenia (lumbar spine bone mineral density \[BMD\] T-score between -1.0 and -2.5, and BMD T-score \> -2.5 at the femoral neck)

Exclusion Criteria:

* Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate)
* Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
* Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.
timeFrame: Baseline, Month 24
measure: Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.
timeFrame: Baseline, Month 24
measure: Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
timeFrame: Months 6, 12, 18 and 24
measure: Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
timeFrame: Months 6, 12, 18 and 24
measure: Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
timeFrame: Months 6, 12, 18 and 24
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: For information regarding facilities, please contact the Central Contact
state: New Jersey
Study officials:
References:
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: McClung M, Miller P, Recknor C, Mesenbrink P, Bucci-Rechtweg C, Benhamou CL. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):999-1007. doi: 10.1097/AOG.0b013e3181bdce0a.