Clinical trial: Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis (NCT00439244)

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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 89 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment