Phase 2
N=154
A Study of LY2541546 in Women With Low Bone Mineral Density
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01144377 ↗Enrolled (actual)
154
Serious AEs
9.2%
Results posted
Dec 2017
Primary outcome: Primary: Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD) — 0.065; 0.115; 0.142; 0.054 g/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2541546 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD) |
0.065; 0.115; 0.142; 0.054; -0.011 | — |
| SECONDARY Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD) |
0.028; 0.048; 0.057; 0.039; -0.007; 0.049 | — |
| SECONDARY Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD) |
0.010; 0.017; 0.026; 0.002; 0.002; 0.007 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD) |
-0.005; -0.005; -0.001; -0.002; -0.005 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP) |
-6.000; -2.000; 1.600; -3.150; -3.900 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx) |
-0.014; -0.088; -0.038; -0.022; 0.037 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Osteocalcin |
-2.087; -0.764; 0.823; -3.322; -2.029 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP) |
-12.250; -4.200; -1.100; -16.050; -5.800 | — |
Summary
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).
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 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.
Data sourced from ClinicalTrials.gov (NCT01144377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.