Clinical trial: Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women (NCT01343004)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age
             (inclusive) with a diagnosis of osteoporosis

          -  The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the
             lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and
             radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic
             vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip,
             femoral, or tibial fracture within the past 5 years. Postmenopausal women older than
             65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be
             enrolled. Women older than 65 who do not meet the fracture criteria may also be
             enrolled if their T score is ≤ -3.0 and > -5.0

          -  Normal physical exam, vital signs, electrocardiogram (ECG) and medical history

          -  Laboratory tests within the normal range including serum calcium, PTH(1-84), serum
             phosphorus and alkaline phosphatase

        Exclusion Criteria:

          -  History of more than 4 mild or moderate spine fractures or any severe fracture

          -  Abnormality of the spine or hip that would prohibit assessment of bone mineral density
             (BMD)

          -  Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such
             as Paget's disease) or a diagnosis of cancer within the last 5 years (with the
             exception of basal cell or squamous cancer of the skin)

          -  History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or
             any chronic or recurrent diseases or disturbances that would interfere with the
             interpretation of study data or compromise the safety of the patient

          -  Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid
             (PTHrP)

          -  Prior treatment with bisphosphonates, fluoride, or strontium within the past five
             years or treatment with androgens, anabolic steroids, corticosteroids or selective
             estrogen receptor modulators within the past 12 months (except hormone replacement
             therapy)

          -  Prior treatment with an investigational drug within the past 12 months

          -  History of nephrolithiasis or urolithiasis within the past five years, or history of
             osteosarcoma at any time
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 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