| Criteria: |
|
Inclusion Criteria:
- Ambulatory, postmenopausal women, inclusive.
- Have low bone mineral density (BMD), defined as a T-score, or equivalent BMD absolute
value (g/cm2), 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 mm3.
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)*, SERMs (Raloxifene,
Tamoxifen, Toremifene, Clomiphene), 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 mg/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 ng/mL
(23nmol/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, patients will receive a loading dose of
Vitamin D (at a dose of approximately 100,000 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 µmol/L or >2.0 mg/dL, alanine
transaminase [ALT/SGPT] >100 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. |
| Study is available at: |
|
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda, MD 20817
United States
Primary Contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559), or
Phone: 1-317-615-4559 |