Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Teriparatide; Denosumab; Demeclocycline; Tetracycline; Calcium Supplement; Vitamin D
Intervention description: Administered SC; Administered SC; Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Vitamin D; Denosumab; Teriparatide; Tetracycline; Demeclocycline; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 55 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine how teriparatide or denosumab affects the bone of
      postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone
      biopsy sample taken from the iliac crest (upper part of the pelvis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory, postmenopausal women (no vaginal bleeding for at least 2 years prior to
             screening) with osteoporosis

          -  Bone mineral density (BMD) T-score of at least -2.5 at femoral neck (FN), total hip
             (TH), or lumbar spine (LS) (Lumbar vertebrae L1-L4, with at least 2 evaluable
             vertebrae), with or without atraumatic fracture after menopause, OR

          -  BMD T-score of at least -1.5 at FN, TH, or LS (L1-L4, with at least 2 evaluable
             vertebrae), and 1 or more atraumatic fractures after menopause (vertebral or
             nonvertebral). Nonvertebral fracture sites allowed are wrist, hip, pelvis, rib,
             humerus, clavicle, leg (femur, tibia, and fibula, excluding ankle)

          -  Laboratory values for serum calcium, parathyroid hormone (PTH), and alkaline
             phosphatase must be within the normal reference range

        Exclusion Criteria:

          -  Has an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of
             bone, a previous bone tumor, or radiation involving the skeleton

          -  Has an allergy or intolerance to teriparatide or denosumab and/or is a poor candidate
             for teriparatide or denosumab treatment (investigator should refer to local product
             prescribing information)

          -  Has a history of exposure to DEM or TET therapy in the 12 months prior to screening or
             a known allergy to DEM or TET

          -  Has a condition that could put the participant at additional risk of an adverse event
             (AE) due to the bone biopsy procedure (for example, bleeding disorder)

          -  Has undergone 2 previous iliac crest bone biopsies (1 in each iliac crest)

          -  Has a 25-hydroxyvitamin D concentration of <10 nanograms per milliliter (ng/mL)

          -  Has currently active or suspected (within 1 year prior to enrollment) diseases that
             affect bone metabolism, other than osteoporosis (such as renal osteodystrophy,
             hyperthyroidism, osteomalacia, or hyperparathyroidism)

          -  Has a history of certain cancers within 5 years prior to trial entry

          -  Current or recent (within 1 year prior to enrollment) celiac disease, inflammatory
             bowel disease, gastric bypass, or other malabsorption syndrome

          -  Has significantly impaired hepatic or renal function

          -  Has had treatment with systemic glucocorticoids in doses ≥5 mg/day prednisone/day or
             equivalent in the 6 calendar months prior to screening

          -  Has taken any intravenous osteoporosis medication

          -  Has had prior treatment with other bisphosphonates and not been off of them for a
             specific period of time before trial entry

          -  Has participated in any other clinical trial studying teriparatide, PTH, PTH analog,
             or denosumab, or prior or current treatment with teriparatide, PTH, PTH analog, or
             denosumab