An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass

Inclusion Criteria:

• A diagnosis of osteoporosis or low bone mass (T score < or = to -1).
• Female, 45 to 75 years old (inclusive).
• Postmenopausal (cessation of menses or oophorectomy) by at least 3 years.
• Bone mineral density: (BMD) at spine or hip >1 standard deviation below mean for young normals of same sex (T score < or = to -1).
• Adequate liver function as indicated by a total bilirubin, AST, and ALT being within institutional normal limits.
• Serum creatinine within institutional normal limits.
• Signed, written informed consent.
• Able to comply with study procedures and follow-up examinations.
• Ionized calcium and 25-hydroxyvitamin D3 must be within institutional normal limits.
• PTH must be within institutional normal limits.

Exclusion Criteria:

• Known hypersensitivity to study drug or related compounds (e.g., bisphosphonates).
• Use of any drugs for treatment of osteoporosis in the previous 6 months (e.g., bisphosphonates, hormone-replacement therapy [HRT]).
• Any chronic or continued use of drugs that are known to affect bone metabolism (e.g., diuretics, glucocorticoids, oral contraceptives).
• Gallstone diagnosed within the past 5 years or a history of multiple gallstones.
• Previous significant gastrointestinal surgery (except appendectomy) or gastrointestinal disease.
• Abnormal thyroid function (by thyroid-stimulating hormone [TSH] assay, normal range 0.5-5.0 U/L).
• Secondary osteoporosis (e.g., steroid-induced) and/or any other disorder affecting calcium or mineral metabolism.
• Use of investigational agents within previous 30 days.
• Patients with existing heart problems (e.g., congestive heart failure, unstable angina, conduction delay).
• Patients taking calcium channel blockers, beta blockers, digitalis, or antihypertensive agents.
• Any other concurrent disease or condition that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.