Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
Condition: Osteoporosis, Post-menopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Teriparatide; Zoledronic Acid
Intervention description: 20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.; 5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Intervention MeSH terms: Zoledronic Acid; Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: Female
Minimum age: 55 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: osteoporosis; teriparatide; zoledronic acid; histomorphometry; bone biopsy; postmenopausal

Summary:

      The purpose of this study is to investigate how teriparatide or zoledronic acid affects the
      bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone
      biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12
      months of treatment all participants are eligible to participate in an additional 12-month
      open label extension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least 2
             years prior to trial entry)

          -  Free of severe or chronically disabling conditions other than osteoporosis that will
             impair ability to complete the trial

          -  Bone mineral density (BMD) T-score of at least -2.5 at the femoral neck, total hip, or
             lumbar spine (L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic
             fracture or,

          -  Bone mineral density (BMD) T-score of at least -1.5 at the femoral neck, or total hip,
             or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), and either 1 or more
             atraumatic vertebral fracture(s) or an atraumatic nonvertebral fracture in the opinion
             of the investigator. Nonvertebral fracture sites allowed are wrist, hip, pelvis, ribs,
             humerus, clavicle, leg (femur, tibia, and fibula, excluding the ankle).

          -  Serum calcium, parathyroid hormone (PTH), alkaline phosphatase must be within normal
             reference range

        Exclusion Criteria:

          -  Have an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of
             bone, a previous bone tumor, or radiation involving the skeleton

          -  Are allergic or cannot tolerate teriparatide or zoledronic acid or any of their
             ingredients or components

          -  Are allergic to tetracycline

          -  Have a history of exposure to tetracycline therapy in the 3 months prior to trial
             entry

          -  Have participated in a prior PTH clinical trial or received prior treatment with
             teriparatide, PTH, or other related medications

          -  Have a vitamin D level below 10 nanogram/milliliter (ng/mL)

          -  Have a condition that could possibly put one at risk for an adverse event due to the
             bone biopsy procedure (e.g. bleeding disorder)

          -  Have undergone two previous iliac crest bone biopsies (one in each iliac crest)

          -  Have taken any intravenous (IV) osteoporosis medication

          -  Have taken other oral osteoporosis medications and have not been off of them for a
             specific period of time before trial entry

          -  Have a history of certain cancers in the 5 years prior to trial entry

          -  Have active liver disease

          -  Have significantly impaired kidney function

          -  Currently have active or suspected diseases that affect the bones, other than
             osteoporosis

          -  Have active or recent history of significant gastrointestinal (stomach or intestinal)
             disorders

          -  Have been treated with certain glucocorticoids for more than 30 days in the past 1
             year prior to trial entry