Clinical trial: Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis (NCT04064411)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy ambulatory female from 50 to 85 years of age (inclusive) with postmenopausal
             osteoporosis

          -  Subjects who are 50 to 65 years old with BMD T score ≤ -2.5 and > -5.0 at the lumbar
             spine or hip (femoral neck or total hip) by DXA and meet one of the following: 1)
             radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic
             vertebral fractures or 2) history of fragility fracture to the forearm, humerus,
             sacrum, pelvis, hip, femur, or tibia within the past 5 years.

          -  Subjects older than 65 years with BMD T score ≤ -2.0 and > -5.0 who meet the fracture
             criteria may be enrolled

          -  Subjects older than 65 years with BMD T score ≤ -3.0 and > -5.0 at the lumbar spine or
             hip (femoral neck or total hip) by DXA

          -  Body mass index of 18.5 to 33 kg/m^2, inclusive

          -  serum calcium (albumin-corrected), PTH(1-84), serum phosphorus, alkaline phosphatase,
             and thyroid stimulating hormone within the normal reference range

          -  Serum 25-hydroxyvitamin D values must be ≥ 20 ng/mL

        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 BMD

          -  History of bone disorders other than postmenopausal osteoporosis or a diagnosis of
             cancer within the last 5 years

          -  History of Cushing's disease, thyroid, parathyroid, 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, parathyroid hormone-related peptide-derived
             drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or
             parathyroid hormone (1-84)

          -  Prior treatment with bisphosphonates within the past 3 years; fluoride or strontium
             within the past 5 years; treatment with corticosteroids within the past 12 months; or
             selective estrogen receptor modulators within the past 6 months (except hormone
             replacement therapy)

          -  Prior treatment with an investigational drug or device within the past 90 days or 5
             half-lives of the investigational drug, whichever is longer

          -  History of nephrolithiasis or urolithiasis within the past 5 years or hereditary
             disorders predisposing to osteosarcoma
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