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Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Zoledronic acid (Drug); Placebo (Drug); Teriparatide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52

Secondary outcome:

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26

Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52

Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)

Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)


Minimum age: 45 Years. Maximum age: 89 Years. Gender(s): Female.


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

Locations and Contacts

Novartis Investigative Site, Bruxelles, Belgium

Novartis Investigative Site, Gent, Belgium

Novartis Investigative site, Godinne, Belgium

Novartis Investigative Site, Leuven, Belgium

Novartis Investigative Site, Liege, Belgium

Novartis Investigative Site, Essen, Germany

Novartis Investigative Site, Hannover, Germany

Novartis Investigative Site, Heidelberg, Germany

Novartis Investigative Site, Magdeburg, Germany

Novartis Investigative Site, Munchen, Germany

Novartis Investigative site, Wuerzburg, Germany

Novartis Investigative Site, Barcelona, Spain

Novartis Investigative Site, Granada, Spain

Novartis Investigative Site, Madrid, Spain

Novartis Investigative Site, Valencia, Spain

Birmingham, Alabama 35294, United States

Beverly Hills, California 90211, United States

Novartis Investigative Site, La Mesa, California, United States

Novartis Investigative Site, Oakland, California, United States

Colorado Springs, Colorado 80910, United States

Lakewood, Colorado 80227, United States

Gainesville, Georgia 30501, United States

Morton Grove, Illinois 60053, United States

Urbandale, Iowa 50322, United States

Bangor, Maine 04401, United States

Novartis Investigative Site, Woodbury, Minnesota, United States

St. Louis, Missouri 63110, United States

Lincoln, Nebraska 68516, United States

Albuquerque, New Mexico 87106, United States

West Haverstraw, New York 10993, United States

Novartis Investigative Site, Pittsburgh, Pennsylvania 15253, United States

Novartis Investigative Site, Spokane, Washington, United States

Madison, Wisconsin 53705, United States

Additional Information

Starting date: December 2006
Last updated: March 23, 2011

Page last updated: August 23, 2015

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