A Study of LY2541546 in Women With Low Bone Mineral Density

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01144377
First received: June 11, 2010
Last updated: April 3, 2013
Last verified: April 2013

June 11, 2010
April 3, 2013
August 2010
May 2012   (final data collection date for primary outcome measure)
Change from baseline to 52 week endpoint in lumbar spine bone mineral density (BMD) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01144377 on ClinicalTrials.gov Archive Site
  • Change from baseline to 12, 24, and 64 weeks in lumbar spine bone mineral density (BMD) [ Time Frame: Baseline, 12 weeks, 24 weeks, 64 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24, 52 and 64 weeks in proximal femur bone mineral density (BMD) [ Time Frame: Baseline, 24 weeks, 52 weeks, 64 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in proximal femur and wrist bone mineral density (BMD) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Bone-specific alkaline phosphatase (BSAP) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Serum type I collagen fragment (CTx) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Osteocalcin [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Serum N-terminal extension propeptide of type I collagen (P1NP) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of LY2541546 in Women With Low Bone Mineral Density
A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women With Low Bone Mineral Density: An Evaluation of the Dose Response Relationship Using Bone Mineral Density

The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo, and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participant's will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: LY2541546
    Administered subcutaneously
  • Drug: Placebo
    Administered subcutaneously
  • Experimental: 180 mg LY2541546 given every 4 weeks
    LY2541546 will be administered subcutaneously every 4 weeks with Placebo given every alternate 2 weeks (Patient will receive an injection every 2 weeks) for 52 weeks.
    Interventions:
    • Drug: LY2541546
    • Drug: Placebo
  • Experimental: 180 mg LY2541546 given every 2 weeks
    Administered subcutaneously for 52 weeks
    Intervention: Drug: LY2541546
  • Experimental: 270 mg LY2541546 given every 2 weeks
    Administered subcutaneously for 52 weeks
    Intervention: Drug: LY2541546
  • Placebo Comparator: Placebo given every 2 weeks
    Administered subcutaneously for 52 weeks
    Intervention: Drug: Placebo
  • Experimental: 270 mg LY2541546 given every 12 weeks
    LY2541546 will be administered subcutaneously every 12 weeks with Placebo given every 2 weeks when LY2541546 is not administered (Patient will receive an injection every 2 weeks) for 52 weeks.
    Interventions:
    • Drug: LY2541546
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
February 2013
May 2012   (final data collection date for primary outcome measure)

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.
Female
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   Estonia,   Japan,   Lithuania
 
NCT01144377
11953, I2M-MC-GSDB
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP