Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00439244

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: Zoledronic acid placebo plus teriparatide Drug: Zoledronic acid Drug: Zoledronic acid plus teriparatide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

• Percent change from baseline in lumbar spine BMD at 52 weeks

Secondary Outcome Measures:

Percent change from baseline in lumbar spine BMD at 26 and 52 weeks
Percent change from baseline in total hip BMD at 13, 26 and 52 weeks
Relative change in serum bone formation marker (P1NP) at 4, 8, 26, 39 and 52 weeks
Relative change in serum bone resorption marker (β-CTx) at 4, 8, 26, 39 and 52 weeks

Estimated Enrollment:	360
Study Start Date:	December 2006
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Zoledronic acid placebo plus teriparatide
2: Experimental	Drug: Zoledronic acid
3: Active Comparator	Drug: Zoledronic acid plus teriparatide

Eligibility

Ages Eligible for Study:	45 Years to 89 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 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 imperfectea or multiple myeloma
Less than 3 evaluable lumbar (L1-L4) vertebrae for 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439244

Show 28 Study Locations

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446H2409
Study First Received:	February 22, 2007
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00439244 History of Changes
Health Authority:	Argentina: National Administration of Drugs, Foods and Medical Technology; Belgium: Directorate general for the protection of Public health: Medicines; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; United States: Food and Drug Administration

Keywords provided by Novartis:

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

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Teriparatide

Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Teriparatide
Physiological Effects of Drugs

Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009