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A Study of LY2541546 in Women With Low Bone Mineral Density

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01144377
First Posted: June 15, 2010
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
June 11, 2010
June 15, 2010
September 27, 2017
December 4, 2017
December 4, 2017
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 ]

Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.

Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.

Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: Baseline, 52 weeks ]
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 and 24 weeks and 64 weeks ]

    Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

    Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.

    Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate

  • Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD) [ Time Frame: Baseline, 24 weeks and 52 weeks and 64 weeks ]

    Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

    Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.

    Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.

  • Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD) [ Time Frame: Baseline, 52 weeks ]

    Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

    Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.

  • Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP) [ Time Frame: Baseline, 52 weeks ]
  • Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx) [ Time Frame: Baseline, 52 weeks ]
  • Change From Baseline to 52 Week Endpoint in Osteocalcin [ Time Frame: Baseline, 52 weeks ]
  • Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP) [ Time Frame: Baseline, 52 weeks ]
  • 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 ]
  • 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 ]
  • Change from baseline to 52 week endpoint in proximal femur and wrist bone mineral density (BMD) [ Time Frame: Baseline, 52 weeks ]
  • Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP) [ Time Frame: Baseline, 52 weeks ]
  • Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx) [ Time Frame: Baseline, 52 weeks ]
  • Change From Baseline to 52 Week Endpoint in Osteocalcin [ Time Frame: Baseline, 52 weeks ]
  • Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP) [ Time Frame: Baseline, 52 weeks ]
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, participants 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: LY2541546
    Administered subcutaneously
    Other Name: Blosozumab
  • Drug: Placebo
    Administered subcutaneously
  • Experimental: 180 mg LY2541546 Q4W + Placebo

    LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks.

    Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.

    Interventions:
    • Drug: LY2541546
    • Drug: Placebo
  • Experimental: 180 mg LY2541546 Q2W
    LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
    Intervention: Drug: LY2541546
  • Experimental: 270 mg LY2541546 Q2W
    LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
    Intervention: Drug: LY2541546
  • Experimental: 270 mg LY2541546 Q12W + Placebo

    LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks.

    Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.

    Interventions:
    • Drug: LY2541546
    • Drug: Placebo
  • Placebo Comparator: Placebo Comparator Q2W
    Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
    Intervention: 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
154
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 (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.
Sexes Eligible for Study: Female
45 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Estonia,   Japan,   Lithuania,   United States
 
 
NCT01144377
11953
I2M-MC-GSDB ( Other Identifier: Eli Lilly and Company )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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
October 2017

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