Clinical trial NCT00666627 (phase 2, status: completed)
Conditions: post-menopausal osteoporosis
ICD codes: M81.6, Z82.62, Z13.820, M81.8, Z87.310, M81.0, M80.80XS
Drugs: ibandronate, risedronate, alendronate
SMILES: CCCCCN(C)CCC(O)(P(O)(O)=O)P(O)(O)=O, OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O, COC1=CC2=C(C=C1)C=C(C=C2)[C@H](C)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  be female

          -  at least 5 years post menopausal but <85 years

          -  BMD T-score (at the lumbar spine or total hip) of less than or equal to

               -  2.5, or T-score less than or equal to -1 with a low trauma fracture.

          -  be ambulatory

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

        Exclusion Criteria:

          -  have evidence of a clinically significant organic disease which could prevent the
             patient from completing the study

          -  have a BMI less than 18 or greater than 35

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

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

          -  have 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 TSH outside the lower limit of the normal range

          -  Hyperparathyroidism

          -  Hypocalcemia or hypercalcemia

          -  Osteomalacia

          -  Cushing's syndrome

          -  Patient who are currently on glucocorticoid therapy

          -  have a serum calcium less than 2.2 mmol/l and a PTH above 75ng/l

          -  have a history of any known condition that would interfere with the assessment of DXA
             at either lumbar spine or femoral neck

          -  have markedly abnormal clinical laboratory parameters that are assessed as clinically
             significant by the investigator

          -  use any of the following medications within 12 months of starting study drug

               -  Bisphosphonates (at any dose)

               -  Use of any fluoride with the exception use for oral hygiene

               -  Strontium

               -  Other bone agents (i.e., SERM, isoflavones, HRT etc)

          -  have participated in another clinical trial involving active therapy 3 months prior to
             randomisation

          -  have a history of allergic reaction to bisphosphonates

          -  patient taking calcium supplements within the last month prior to randomisation

          -  We will exclude patients with secondary osteoporosis, those who have been on
             anti-resorptive treatments in the past year, and women less than 5 years since
             menopause, and those with bilateral fractures in the measurement regions (heel, hip
             and forearm).

          -  Have suffered a recent fracture within the last 12 months