Clinical trial: A Study of LY2541546 in Women With Low Bone Mineral Density (NCT01144377)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory, postmenopausal women, inclusive.

          -  Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute
             value (grams/square centimeter [g/cm^2]) for the lumbar spine of between -3.5 and
             -2.0, inclusive.

          -  Without language barrier, reliable, and willing to make themselves available for the
             duration of the study and to follow study procedures.

          -  Willing to take study drug and daily supplements (calcium and Vitamin D).

          -  Normal laboratory tests or laboratory test results determined not clinically
             significant by the investigator. Serum phosphate and serum calcium must be within
             normal limits, and platelet level greater than 100,000 cubic millimeters (mm^3).

        Exclusion Criteria:

          -  Have received treatment with any of the following medications more recently than 3
             months prior to screening Androgen, Calcitonin, Estrogen (including over the counter
             preparations known to have estrogenic activity), Progestin (including over the counter
             preparations known to have progestogenic activity), selective estrogen receptor
             modulators (SERMs) (Raloxifene, Tamoxifen, Toremifene, Clomiphene), or Tibolone.

          -  Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH
             analogs, strontium ranelate, or parenteral formulations of bisphosphonates.

          -  Have received treatment with any oral bisphosphonate within the last year.

          -  Have received therapeutic doses of systemic corticosteroids for more than one month
             during the 6 months prior to screening.

          -  Have received therapeutic doses of fluorides (20 milligrams per day) for more than 3
             months during the last 3 years, or for more than a total of 2 years, or any within the
             last 6 months.

          -  Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <9.2
             nanograms per milliliter (ng/mL) [23 nanomoles per liter (nmol/L)] at screening. If
             the serum 25-hydroxy-vitamin D level at screening is less than or equal to 9.2 ng/mL
             and <20 ng/mL, participants will receive a loading dose of Vitamin D (at a dose of
             approximately 100,000 international units (IU) given orally) prior to enrollment.

          -  Have any known bone disorder other than low BMD or osteoporosis.

          -  Have a history of osteoporotic fractures, including known prevalent vertebral fracture
             or evidence of prevalent vertebral fracture on screening spine X-ray or dual-energy
             x-ray absorptiometry (DXA), or are considered to be at high risk for fracture.

          -  Presence of any abnormality (such as artifacts or osteophytes) that would confound DXA
             evaluation of lumbar vertebrae in the L-1 through L-4 region.

          -  Have a history of Bell's palsy, other cranial nerve disorders, or have a history of
             Temporomandibular Joint and Muscle Disorders (TMJDs).

          -  Have any history of cancer within the previous 5 years, except for excised superficial
             lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.

          -  Have history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             constituting a risk when taking the study medication or of interfering with the
             interpretation of data.

          -  Have acute or chronic liver disease ([bilirubin >34 micromoles per liter (µmol/L) or
             >2.0 milligrams per deciliter (mg/dL), alanine transaminase [ALT/SGPT] >100 units per
             liter (U/L), or alkaline phosphatase >300 U/L)].

          -  Have impaired kidney function serum creatinine >135 µmol/L or >2.0 mg/dL.

          -  Have known allergy to LY2541546, any of diluents or excipients of LY2541546, or
             significant allergy to any other monoclonal antibody.

          -  History of excessive consumption of alcohol or abuse of drugs within the last year.

          -  Have poor medical condition or psychiatric risks for treatment with an investigational
             drug.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 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