Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 69
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: 20 micrograms (µg) teriparatide administered subcutaneously (SC) once every day for 6 months.

Demeclocycline (DEM): Beginning 18 days prior to randomization: Days 1, 2, 3 and 16, 17, 18: 150 milligrams (mg) DEM will be taken orally every 6 hours; Days 4 to15: DEM will not be administered.

Tetracycline (TET): Beginning 22 days prior to the biopsy procedure: Days 1, 2, 3 and 16, 17, 18: 250 mg TET will be taken orally every 6 hours; Days 4 through 15: TET will not be administered.

Calcium: Approximately 1000 milligrams per day (mg/day) administered orally.

Vitamin D: Approximately 800 to 1200 International Units per day (IU/day) administered orally. arm 2: 60 mg denosumab administered SC once in 6 months.

DEM: Beginning 18 days prior to randomization: Days 1, 2, 3 and 16, 17, 18: 150 mg DEM will be taken orally every 6 hours; Days 4 to 15: DEM will not be administered.

TET: Beginning 22 days prior to the biopsy procedure: Days 1, 2, 3 and 16, 17, 18: 250 mg TET will be taken orally every 6 hours; Days 4 through 15: TET will not be administered.

Calcium: Approximately 1000 mg/day administered orally.

Vitamin D: Approximately 800 to 1200 IU/day administered orally.

Interventions: intervention 1: Teriparatide intervention 2: Denosumab intervention 3: Demeclocycline intervention 4: Tetracycline intervention 5: Calcium Supplement intervention 6: Vitamin D
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered orally intervention 6: Administered orally

Protocol document: