Clinical trial: Early Effects of Abaloparatide on Tissue-based Indices of Bone Formation and Resorption (NCT03710889)

Eligibility criteria:
Inclusion Criteria

        Subject must meet all of the following criteria to be eligible to participate in this
        study:

          1. The subject is a healthy ambulatory postmenopausal female from 50 to 85 years of age
             (inclusive) with osteoporosis.

          2. The subject has been postmenopausal for at least 5 years. Postmenopausal status will
             be established by a history of amenorrhea for at least 5 years and by an elevated
             follicle stimulating hormone (FSH) value of ≥ 30 IU/L.

          3. The subject has a BMD T-score ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck
             or total hip) by DXA or lumbar spine or hip BMD T-score ≤ -2.0 with a history of low
             trauma vertebral, forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture
             sustained within 5 years prior to enrollment. These fractures must be documented by
             radiograph or hospital report.

          4. The subject is in good general health as determined by medical history and physical
             examination (including vital signs), has a body mass index (BMI) of 18.5 to 33,
             inclusive, and is without evidence of clinically significant abnormality in the
             opinion of the Investigator.

          5. The subject has serum calcium (albumin-corrected), PTH (1-84), phosphorus, and
             alkaline phosphatase levels all within the normal range during the Screening Period.
             Any patient with an elevated alkaline phosphatase value, and who meets all other entry
             criteria, is required to have a normal bone-specific alkaline phosphatase result to be
             enrolled.

          6. The subject has serum 25-hydroxyvitamin D values ≥ 20 ng/mL and within the normal
             range. Patients with serum 25-hydroxyvitamin D levels < 20 ng/ml may be treated with
             vitamin D3 and re-tested once.

          7. The subject's resting 12-lead electrocardiogram (ECG) obtained during screening shows
             no clinically significant abnormality.

          8. The subject has read, understood, and signed the written informed consent form.

        Exclusion Criteria:

        Subjects with any of the following characteristics are not eligible to participate in the
        study:

          1. Presence of abnormalities of the lumbar spine that would prohibit assessment of lumbar
             spine BMD, defined as having at least 2 radiologically evaluable vertebrae within
             L1-L4.

          2. Unevaluable hip BMD or patients who have undergone bilateral hip replacement
             (unilateral hip replacement is acceptable).

          3. History of bone disorders (eg, Paget's disease) other than postmenopausal
             osteoporosis.

          4. Clinically significant abnormality of serum hemoglobin, hematocrit, white blood cells
             (WBC) and platelets, coagulation, or usual serum chemistry: electrolytes, renal
             function, liver function and serum proteins.

          5. Unexplained elevation of serum alkaline phosphatase.

          6. History of radiotherapy (radiation therapy), other than radioiodine.

          7. History of bleeding disorder that would preclude a bone biopsy, in the opinion of the
             Investigator.

          8. History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular,
             gastrointestinal, endocrine, central nervous system, hematologic or metabolic
             diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that
             would interfere with the interpretation of study data or compromise the safety of the
             patient.

          9. History of Cushing's disease, hyperthyroidism, hypo- or hyperparathyroidism, or
             malabsorptive syndromes within the past year.

         10. History of significantly impaired renal function (serum creatinine > 177 µmol/L or >
             2.0 mg/dL). If the serum creatinine is > 1.5 and ≤ 2.0 mg/dL, the calculated
             creatinine clearance (Cockcroft-Gault) must be ≥ 30 mL/min.

         11. History of any cancer within the past 5 years (other than basal cell or squamous cell
             cancer of the skin).

         12. History of osteosarcoma at any time or a history of hereditary disorders which could
             predispose the patient to osteosarcoma.

         13. History of nephrolithiasis or urolithiasis within the past five years.

         14. Subjects known to be positive for hepatitis B, hepatitis C, human immunodeficiency
             virus infection (HIV-1 or HIV-2). Testing is not required in the absence of clinical
             signs and symptoms suggestive of HIV infection or acute or chronic hepatitis.
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