Clinical trial NCT00439244: Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
Official title: A One-year Partial Double-blinded, Randomized, Multi-center, Multi-national Study to Assess the Effects of Combination Therapy of Annual Zoledronic Acid (5 mg) and Daily Subcutaneous Teriparatide (2mcrg) on Postmenopausal Women With Severe Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Bone Mineral Density (BMD)
C-Telopeptides (CTx)
dual x-ray absorptiometry (DXA)
pro-collagen type 1 N-propeptide (P1NP)
teriparatide
zoledronic acid
Osteoporosis
postmenopausal women
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-23
Enrollment: 412
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip


Eligibility criteria: Inclusion criteria:

* Postmenopausal (PMO) women between 45 and 89 years of age.
* Bone mineral density T score of -2.5 or less at femoral neck, total hip or lumbar spine OR
* Bone mineral density T score of -2.0 or less at femoral neck, total hip or lumbar spine with at least one documented osteoporotic vertebral fracture or a previously documented history of an osteoporotic clinical non-vertebral fracture not due to excessive trauma

Exclusion criteria:

* Any prior use of strontium
* Any past or active kidney disease or problems with kidney function
* Prior treatment with any intravenous (i.v.) or oral bisphosphonate (such as but not limited to alendronate, risedronate and pamidronate) longer than 3 months consecutively. If bisphosphonate exposure is less than or equal to 3 months , a washout period of 1 year to randomization is required
* Calcium levels in blood within the normal range
* Normal liver function
* Non-osteoporotic forms of metabolic bone disease such as and not limited to Paget's disease of bone, osteomalacia, osteogenesis imperfecta or multiple myeloma
* Less than 3 evaluable lumbar (L1-L4) vertebrae for dual energy x-ray absorptiometry (DXA) measurement
* Treatment with osteoporotic therapies such as raloxifene, calcitonin or Hormone Replacement Therapy within 3 months of randomization
* Allergy or previous exposure to teriparatide

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
timeFrame: Baseline through Week 52
Secondary outcomes:
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26
timeFrame: Baseline through Week 13 and Week 26
measure: Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52
timeFrame: Baseline through Week 13, Week 26 and Week 52
measure: Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)
timeFrame: At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
measure: Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)
timeFrame: At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Beverly Hills
country: United States
state: California
city: La Mesa
country: United States
facility: Novartis Investigative Site
state: California
city: Oakland
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Gainesville
country: United States
state: Georgia
city: Morton Grove
country: United States
state: Illinois
city: Urbandale
country: United States
state: Iowa
city: Bangor
country: United States
state: Maine
city: Woodbury
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: West Haverstraw
country: United States
state: New York
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Godinne
country: Belgium
facility: Novartis Investigative site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
Study officials:
References: