Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Calcium; Calcium, Dietary; Demeclocycline; Denosumab; Ergocalciferols; Teriparatide; Tetracycline; Vitamin D; Vitamins

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