Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

Korábbi kezelés

• Participation in a study of an investigational drug during the past 30 days.
• Treatment with anabolic or antiresorptive bone drugs.
• Planned or anticipated oral surgery within the next 12 months.
• Chronic alcoholism and/or drug addiction.
• Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)).

Más betegség

• Allergy to the antibiotics demeclocycline or tetracycline.
• Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 Diabetes Mellitus).
• Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections).
• Abnormalities of the esophagus (tube connecting the mouth to the stomach) which delay esophageal emptying such as stricture (narrowing) or achalasia (a condition that prevents normal swallowing).
• Have a history of malignancy (cancer), not including non-melanoma skin cancer.

Életkor

• Have other bone diseases that are not linked to age or menopause.

Egyéb

• Pregnant or trying to become pregnant or are breastfeeding.
• Use of systemic anticoagulation (blood thinner)
• Planning to move out of the area within 18 months of the study.
• Inability to stand or sit upright for at least 30 minutes.
• Vitamin D (Calcidiol) level below the normal range (below 20ng/mL).
• AFTER RANDOMIZATION: If randomized to Group 1 Teriparatide and radius BMD t-score is less than -3.5 and does not sign consent to continue in the study.

• Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures)
• Treatment naive with respect to with anabolic or antiresorptive bone drugs.
• Premenopausal, menopausal, and post-menopausal females.
• 45 years old and older.
• Presence or absence of diabetes
• Normal levels of Vitamin D
• Absence of all exclusion criteria on clinical workup
  • Patients diagnosed as osteoporotic due to the presence of fragility fractures, but without osteoporotic t-scores, will not be included because they would require fractures as a study endpoint which would entail a multi-center approach. Moreover, abnormal bone quality has been shown to be present in these patients, which requires bone histology for assessment.