Clinical trial: Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD (NCT00624481)

Eligibility criteria:
Inclusion Criteria:

          -  Postmenopausal Female patients up to 89 years, inclusive;

          -  BMI ≤ 35 kg/m2, inclusive;

          -  In good health, determined by medical history and physical examination, as well as
             normal 12-lead ECG and vital signs;

          -  Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1
             year, surgically sterile (including tubal ligation, hysterectomy) for at least 3
             months, until 30 days following Study Completion be willing to use an approved method
             of contraception;

          -  Have a minimum of two evaluable non-fractured lumbar vertebrae.

          -  Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA
             scan at either the lumbar spine (L1-L4) or total hip

        Exclusion Criteria:

          -  Serious Medical Condition

          -  History of diseases which affect bone metabolism other than postmenopausal
             osteoporosis such as Paget's disease, any secondary causes of osteoporosis,
             hypoparathyroidism, or hyperparathyroidism

          -  Have a history of cancer within the past 5 years, except for basal cell carcinoma

          -  Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney
             stones or pre-existing hypercalciuria;

          -  Have used any of the mostly commonly prescribed osteoporosis medications within 3
             months of starting the investigational product, or for more than 1 month at any time
             within 6 months prior to starting investigational product.
Female
No healthy subjects accepted to join the trial.

Subject must be at most 89 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