Clinical trial: Resolution of Effect of Bisphosphonates on Bone in Postmenopausal Osteoporosis (NCT01406613)

Eligibility criteria:
Inclusion Criteria:

        Inclusion Criteria for postmenopausal women

          -  female be at least 7 years postmenopausal but less than 87 years of age

          -  be ambulatory

          -  be able and willing to participate in the study and provide written informed consent.

          -  have taken a bisphosphonate for 2 years as a participant in the TRIO study and be
             compliant > 80%

          -  have a Bone Mineral Density (BMD) T score > -2.5 at the femoral neck

        Inclusion Criteria for premenopausal women

          -  be able and willing to participate in the study and provide written informed consent

          -  have previously taken part as premenopausal controls in the TRIO study

          -  be in good general health as determined by past medical and physical history

          -  be bisphosphonate naive; premenopausal women.

        Exclusion Criteria:

        Exclusion Criteria for postmenopausal women:

          -  An incident vertebral fracture or more than 5%/year bone loss at the spine or hip
             during the 2-year TRIO study

          -  Evidence of a clinically significant organic disease which could prevent the patient
             from completing the study, including diabetes

          -  Abuse of alcohol or use of illicit drugs or who consumed more than 4 units of any
             alcoholic beverage one day prior to the visit (i.e. subjects who might be binge
             drinkers)

          -  A history of cancer within the past 5 years excluding skin cancer non melanomas

          -  A history of ongoing conditions or diseases known to cause abnormalities of calcium
             metabolism or skeletal health (secondary osteoporosis)

          -  Chronic renal disease (as defined by a creatinine clearance of ≤ 30ml/min)

          -  Acute or chronic hepatic disease

          -  Malabsorption syndromes

          -  Hyperthyroidism as manifested by Thyrotrophin-stimulating hormone (TSH) outside the
             lower limit of the normal range

          -  Hyperparathyroidism

          -  Hypocalcemia or hypercalcemia

          -  Osteomalacia

          -  Cushing's syndrome

          -  Current use of glucocorticoid therapy

          -  A serum calcium less than 2.2 mmol/l and a Parathyroid hormone (PTH) above 75ng/l

          -  A history of any known condition that would interfere with the assessment of
             Dual-emission X-ray absorptiometry (DXA) at either lumbar spine or femoral neck

          -  Markedly abnormal clinical laboratory parameters that are assessed as clinically
             significant by the principal investigator

          -  Require, in the opinion of the consulting physician, continuation of bisphosphonate
             therapy.

        Exclusion Criteria for premenopausal women:

          -  Are pregnant or nursing (lactating)

          -  Use of any hormonal forms of contraception/ therapy within the past 2 years that
             would, in the opinion of the consulting physician, affect bone metabolism.

          -  Use of anabolic agents such as steroids or PTH, or any bisphosphonate within the past
             2 years.

          -  Have any history of cancer within the past 5 years. Relatively benign skin
             malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an
             exclusion if the patient has been in remission for at least 6 months prior to
             enrolment.

          -  Have any chronic disease (HIV or AIDs, clinically significant renal or cardiovascular
             disease, hyperthyroidism, diabetes, hyperlipidemia) or menstrual cycle irregularity
             (by history)).

          -  Have any metabolic bone disease, such as osteoporosis, Paget 's disease, osteogenesis
             imperfecta, or serious illness affecting normal bone homeostasis (by history and
             physical exam if required)

          -  Significant use of any medications known to affect bone metabolism (such as Phenytoin
             or other anticonvulsants, Selective Estrogen Receptor Modulators (SERMs), heparin or
             systemic glucocorticosteroids) within the past 2 years.

          -  Have suffered a fracture within the last 12 months

          -  Have anorexia nervosa, suspected bulimia (by history or physical) or obvious
             malnutrition

          -  Have a history of alcoholism, or who have consumed more than 4 units of any alcoholic
             beverage one day prior to the visit (i.e., subjects who might be binge drinkers)

          -  Have previously participated in active therapy clinical trials within the last 3
             months
Female
Accepts Healthy Volunteers

Subject must be at most 87 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction