Clinical trial: Study to Evaluate the PK, PD and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density (NCT04366726)

Eligibility criteria:
Inclusion Criteria:

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

          -  Postmenopausal for at least 2 years.

          -  BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine
             (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA).

        Every effort was made to enroll subjects with a T-score of -2.0 or lower but > -5.0

          -  Good general health as determined by medical history and physical exam (including
             vital signs, and has a body mass index up to 33 kg/m^2

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

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

        Exclusion Criteria:

          -  History of prior external beam or implant radiation therapy involving the skeleton,
             other than radioiodine

          -  History of bone disorders other than postmenopausal osteoporosis (such as Paget's
             disease)

          -  Diagnosis of cancer within the last 5 years (with the exception of basal cell or
             squamous cancer of the skin)

          -  History of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes
             within the past year

          -  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 intravenous bisphosphonates at any time or oral bisphosphonates
             within the past year (12 months). Subjects who have received a short course of oral
             bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment
             occurred 6 or more months prior to enrollment

          -  Prior treatment with an investigational drug or device within the past 3 months or 5
             half-lives of the investigational drug, whichever is longer
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? 1