A study of LY2541546 in Women with Low Bone Mineral Density

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 132

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Ambulatory, postmenopausal women between 45 and 85 years of age, inclusive. Postmenopausal is defined as:
- At least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy (confirmed by operative note if without hysterectomy) or,
- Spontaneous amenorrhea, that is not induced by a medical condition such as anorexia nervosa or by medications (such as oral contraceptives, hormones, gonadotropin-releasing hormone [GnRH], anti-estrogens, selective
estrogen receptor modulator [SERMs], chemotherapy), for at least 12 months, or for at least 6 months with a serum follicle-stimulating hormone (FSH) level >40 mIU/mL and a negative pregnancy test, or,
- Hysterectomy prior to menopause and at least 2 years prior to randomization; if =60 years old, both serum estradiol level <73 pmol/L (20 pg/mL) and FSH level >30 mIU/mL.
[2] Have low BMD, defined as a T-score for lumbar spine of between –3.5 and -2.0, inclusive, based on the local DXA report as interpreted by the investigator. The method of determining T-score values will be based on regional standards. Three of 4 vertebrae, L1 through L4, must be evaluable for BMD scoring, as measured by DXA.
[3] Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures.
[4] Willing to receive study drug and take daily supplements (calcium and Vitamin D).
[5] Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
[6] Are investigator site personnel directly affiliated with this study and/or their immediate families.
[7] Are Lilly employees.
[8] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
[9] Have previously completed or withdrawn from this study or any other study investigating LY2541546.
[10] Have received treatment with any of the following medications more recently than 3 months prior to screening:androgen, Calcitonin, SERMs, Tibolone
[11] Recent initiation of hormone replacement therapy.
[12] Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
[13] Have received treatment with any oral bisphosphonate within the last year or within the last 3 years. The patient may be enrolled if, as assessed by the investigator, she has taken clinically insignificant amounts of oral bisphosphonate.
[14] Have received therapeutic doses of systemic corticosteroids for more than 1 month during the 6 months prior to screening.
[15] 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.
[16] Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <10 ng/mL (25 nmol/L) at the screening visit.
[17] Have any known bone disorder other than low BMD or osteoporosis.
[18] Have a history of osteoporotic fractures, such as a fracture occurring during the menopausal years, but also including known prevalent vertebral fracture or evidence of prevalent vertebral fracture on screening spine X-ray or DXA. In addition, if the patient is considered to have a high risk for fracture as assessed by the investigator, based for example on age and T-score, they should be excluded.
[19] Have a history of Bell's palsy, other cranial nerve damage, or have a history of a temporomandibular joint disorder (TMJD).
[20] 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.
[21] In the opinion of the investigator, the patient represents an unacceptable medical or psychiatric risk for treatment with an investigational drug.
[22] Have known allergy to LY2541546, any of the diluents or excipients of LY2541546, or significant allergy to any other monoclonal antibody
[23] History of excessive consumption of alcohol or abuse of drugs within the last year, as assessed by the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials