Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-5442 · 1 trial · 2 indications
Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm\^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm
Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (\>2.5 mmol/L). Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a "Tier 1" adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons.
Albumin-Corrected Calcium = (\[4 - plasma albumin in g/dL\] × 0.8 + serum calcium). ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a "Tier 1" AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).
Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment. |
| MK-5442 5 mg | EXPERIMENTAL | Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment. |
| MK-5442 7.5 mg | EXPERIMENTAL | Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment. |
| MK-5442 10 mg | EXPERIMENTAL | Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment. |
| MK-5442 15 mg | EXPERIMENTAL | Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment. |
| Alendronate 70 mg | ACTIVE_COMPARATOR | Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment. |
| Name | Type | Description |
|---|---|---|
| MK-5442 | DRUG | MK-5442 tablets (randomized to a dose of 5, 7.5, 10 or 15 mg) taken orally, once-daily, for 12 months |
| Placebo to MK-5442 | DRUG | Matching placebo to MK-5442 taken orally, once-daily, for 12 months |
| Alendronate Sodium | DRUG | Alendronate tablets 70 mg, taken orally, once-weekly, for 12 months |
| Vitamin D3 | DRUG | Vitamin D3 (cholecalciferol) administered orally, at a dose of 5600 IU (two tablets, 2800 IU each), once-weekly for 12 months |
| Calcium carbonate | DRUG | Participants who qualify (those who have a calcium intake of less than 1200 mg/day) will receive oral supplemental calcium carbonate, at a dose of either 400 mg or 500 mg, once-daily, for 12 months |
| Placebo to Alendronate | DRUG | Placebo to alendronate once-weekly for 12 months |
Inclusion Criteria: * Taking oral bisphosphonate treatment for osteoporosis for at least 3 of the past 4 years. At present, and for the past 12 months, treated with alendronate * Bone Mineral Density (BMD) T-score that is ≤ -1.5 at one or more of the following anatomic sites; lumbar spine, femoral ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
MK-5442 is an investigational small molecule being developed for the treatment of osteoporosis, specifically in postmenopausal women. It is being studied as a potential therapy for patients who have previously been treated with an oral bisphosphonate. The drug is currently in Phase 2 clinical development.
MK-5442 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating osteoporosis.
MK-5442 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its potential as a treatment for osteoporosis in postmenopausal women.
MK-5442 has been studied in a Phase 2 clinical trial registered as NCT00996801, titled "MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)." This trial enrolled 526 participants and has been completed.
Yes, MK-5442 is being studied in postmenopausal women with osteoporosis. The completed Phase 2 trial enrolled female participants aged 45 years and older who had previously been treated with an oral bisphosphonate. The study was randomized, double-blind, and placebo-controlled.