Clinical trial: Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial (NCT00239629)

Eligibility criteria:
INCLUSION CRITERIA:

          1. Ambulatory, postmenopausal women aged 45 to 90 years inclusive at the time of entry
             into the trial, whose last menstrual period or bilateral oophorectomy occurred at
             least 5 years prior to entry into the trial. Women below the age of 55 years in whom a
             bilateral oophorectomy cannot clearly be documented must have their postmenopausal
             status confirmed by a serum FSH level greater or equal to 30 IU/L and serum estradiol
             level lower or equal to 20 pg/ml or lower or equal to 73 pmol/L.

          2. Free of severe or chronically disabling conditions other than osteoporosis.

          3. Able to use a pen-type injection delivery system satisfactorily in the opinion of the
             investigator and willing to be trained on and use the pen-injector on a daily basis.

          4. Without language barrier, cooperative, expected to return for all follow-up
             procedures, and have given informed consent after being informed of the risks,
             medications, and procedures to be used in the study.

          5. Posterior-anterior lumbar spine (L-1 through L-4) BMD and/or femoral neck BMD and/or
             total hip BMD measurement at least 2.5 standard deviations (SD) below the average bone
             mass for young women (T-score below or equal to -2.5 standard deviations). The lumbar
             spine and hip BMD assessment and the determination of the patient's eligibility for
             entry into the screening phase will be made by the individual investigator. Any lumbar
             vertebra that cannot be analyzed due to artifacts, severe crush fracture, osteophytes,
             or other abnormalities, should be excluded from the analysis. A minimum of two lumbar
             vertebrae in the L-1 through L-4 region must be evaluable by DXA if this is the only
             anatomical site where the BMD cut-off level less than -2.5 SD is demonstrated. A DXA
             assessment performed within three months prior to Visit 1 may be acceptable for
             patient's eligibility.

          6. Normal or clinically insignificant abnormal laboratory values (as defined by the
             investigator) including serum calcium, PTH(1 84), alkaline phosphatase.

             EXCLUSION CRITERIA:

          7. History of unresolved skeletal diseases that affect bone metabolism other than
             postmenopausal osteoporosis including Paget's disease, renal osteodystrophy,
             osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected),
             and intestinal malabsorption.

          8. In the opinion of the investigator, have any medical or anatomical condition that
             potentially could put the patient at additional risk of an adverse event due to the
             biopsy procedure (for example, coagulation abnormality, anticoagulant medication,
             extreme obesity, etc).

          9. Have undergone two previous iliac bone biopsies (one in each iliac crest). Patients
             with one previous iliac bone biopsy are eligible provided that the new sample is
             obtained from the contralateral iliac crest.

         10. History of malignant neoplasms in the 5 years prior to Visit 1, with the exception of
             superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been
             definitively treated. Patients with carcinoma in situ of the uterine cervix treated
             definitively more than 1 year prior to entry into the study may be randomized.

         11. Increased baseline risk of osteosarcoma; this includes subjects with Paget's disease
             of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic
             irradiation, i.e. prior external beam or implant radiation therapy. As an elevation of
             serum skeletal alkaline phosphatase activity may indicate the presence of Paget's
             disease, an unexplained elevation of this enzyme activity will also be exclusionary.

         12. Abnormal thyroid function not corrected by therapy. Normal thyroid function may be
             documented by a normal TSH during the screening phase or a combination of clinical and
             biochemical parameters which, in the judgment of the investigator and the Lilly
             Clinical Research Physician, sufficiently establishes the presence of normal thyroid
             function.

         13. Active liver disease or clinical jaundice.

         14. Significantly impaired renal function as defined by either of the following criteria:

               -  Serum creatinine that, in the opinion of the investigator, indicates significant
                  renal impairment.

               -  Measured or calculated endogenous creatinine clearance less than 30 mL/min using
                  the following Cockcroft Gault formula for creatinine clearance (ClCr) for women:

             ClCr (mL/minute) = [[(140-age) x weight (kg)]x0.85] / [72 x serum Cr (mg/dL)]

         15. Current or past treatment with any bisphosphonate, parathyroid hormone or its analogs,
             androgens or other anabolic steroids or therapeutic doses of fluorides at any time
             prior to Visit 2.

             Past treatment (more than 12 months before Visit 2) with a selective estrogen receptor
             modulator (SERM), nasal or injectable calcitonin, oral, transdermal, or injectable
             estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists or
             tibolone is allowed. Previous or current use of fluoridated water or topical dental
             fluoride treatments are permitted.

         16. Treatment with Vitamin D greater than 50,000 IU/week, or with any dose of calcitriol
             or Vitamin D analogs or agonists in the 6 months prior to Visit 2.

         17. Treatment with systemic corticosteroids in the last month prior to Visit 2 or for more
             than 14 days in the 1 year prior to Visit 2. Ophthalmic, otic, topical, orally
             inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used
             without these restrictions. However, orally inhaled or nasally inhaled corticosteroids
             in doses greater than 840 micrograms/day beclomethasone dipropionate or equivalent for
             more than 14 days in the last year prior to randomization will be disqualifying.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 90 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? Entailment