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

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