Clinical trial: Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis (NCT01465568)

Eligibility criteria:
Inclusion Criteria:

          1. Women or adult men (>18 years of age) with various medical diseases requiring
             long-term prednisolone treatment. Pre-menopausal women should have no plan for
             pregnancy within 2 years of study entry and agree to practice contraception during
             this 2-year period.

          2. A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of
             study entry.

          3. Having received oral bisphosphonate treatment for at least 2 years.

          4. Suboptimal response to bisphosphonate treatment, defined as either one of the
             following: (1) failure of lumbar spine, femoral neck or total hip BMD values to
             increase; (2) values of lumbar spine, femoral neck or total hip BMD remain
             osteoporotic, ie. T scores < -2.5 or Z scores < -2.0; or (3) development of new
             fragility vertebral or non-vertebral fractures despite at least 2 years' treatment
             with good compliance.

          5. Informed consent from patients.

        Exclusion Criteria:

          1. Patients with previous use of denosumab or teriparatide.

          2. Premenopausal women who plan for pregnancy within 2 years of study entry or who do not
             agree for contraception within this 2-year period.

          3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and
             hyperparathyroidism.

          4. Patients with unexplained hypocalcemia.

          5. Patients with serum creatinine level of >=200umol/L.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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