Mechanisms of Anabolic Osteoporosis Therapy

Korábbi kezelés

• any prior exposure to romosozumab.

Más betegség

• renal disease (stage 4 CKD)
• major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
• known congenital or acquired bone disease other than osteoporosis.

Laborértékek

• serum 25-OH vitamin D < 20 ng/ml

Egyéb

• elevated blood PTH (intact PTH > 77 pg/ml).
• excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures.
• exposure to oral bisphosphonates within the past 3 months, denosumab in the last 12 months, intravenous bisphosphonates within the past 24 months.
• exposure to estrogens, SERMs, or calcitonin, oral or parenteral glucocorticoids for more than 14 days in the past 2 months.

• All postmenopausal women who are prescribed romosozumab by their treating physicians, meet the FDA-defined indication for romosozumab, and who are not at increased risk for a bone marrow aspirate or bone biopsy will be offered enrollment. The FDA approved indication for romosozumab is: "the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy." Volunteers must be:
• Female aged > 45 years
• Postmenopausal by either of the following criteria:
  • > 36 since last spontaneous menses
  • > 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years