Clinical trial: Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone (NCT04467983)

Eligibility criteria:
Inclusion Criteria:

          -  postmenopausal woman >age 45 of any racial origin

          -  Participants will have received at least 4 prior denosumab treatments and be within 7
             months from their last denosumab injection

          -  Participants are willing to participate for the duration of the study and have no
             physical or psychological illness that would prohibit them from participating.

          -  Diagnosis of osteoporosis based on bone mineral density and/or fracture criteria.
             Osteoporosis will be defined by bone mineral density T-Score < -2.5 at lumbar spine
             (at least 2 evaluable vertebrae between L1 and L4), total hip or femoral neck.
             Osteoporosis will also be defined clinically in women with osteoporotic fractures
             within the preceding 5 years, including clinical vertebral or nonvertebral fractures
             or vertebral fracture confirmed by radiograph or lateral DXA VFA image, along with a
             DXA BMD T-Score < -1.5 at one or more skeletal sites.

        Exclusion Criteria:

          -  Use of drugs other than denosumab (within the preceding 3 months) known to affect
             skeletal or calcium homeostasis.

          -  Fewer than 2 evaluable lumbar vertebrae

          -  A history of a symptomatic renal stone within the past 2 years or history of multiple
             symptomatic renal stones within the preceding 10 years

          -  Skeletal Disorders other than osteoporosis, including hypercalcemia,
             hyperparathyroidism, or Paget's Disease

          -  History of external or internal radiation therapy

          -  Estimated GFR below 30 ml/min

          -  Any contraindications to receipt of Abaloparatide or Denosumab

          -  History of any cancer in past 5 years (except basal/squamous skin cancer)

          -  Unexplained elevation of Serum Alkaline Phosphatase

          -  History of atypical femoral fracture
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.


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? Contradiction