None listed
Conditions
Interventions
Group 1 Type of group
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.
Group name:Group 6 Type of group
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.
Sponsors
MERCK & CO.INC.,
Eligibility
Sex/Gender
Female
Age
45 Years to 85 Years
Inclusion criteria
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 neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0, AND a history of at least one fragility fracture, OR, a BMD T-score that is ≤ -2.5 at one or more of the following anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0 • Postmenopausal for at least 5 years
Exclusion criteria
Exclusion criteria: • Obesity (ie, weight greater than 250 pounds) that prohibits the use of dual-emission X-ray absorptiometry (DXA) • Received intravenous (IV) bisphosphonates, fluoride treatment at a dose >1 mg/day for more than 2 weeks, strontium, growth hormone, a cathepsin K (CTSK) inhibitor, or a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor at any time in the past • Use of oral bisphosphonates other than alendronate in the last 12 months, parathyroid hormone (PTH) in the last 24 months, cyclosporin for more than 2 weeks in the last 6 months, heparin in the last 2 weeks, or anabolic steroids or glucocorticoids for more than 2 weeks in the past 6 months • Use of estrogen with or without progestin or a selective estrogen receptor modulator (SERM) in the last 6 months or calcitonin in the last 30 days • Has used pioglitazone hydrochloride or rosiglitazone hydrochloride in the last 6 months • Taking more than 10,000 International Units (IU) vitamin A daily or more than 5,000 IU vitamin D daily • Has had a total thyroidectomy • History of Paget´s disease • Has human immunodeficiency virus (HIV) • History of cancer in the last 5 years, except certain skin or cervical cancers • History of major upper gastrointestinal (GI) mucosal erosive disease • Unable to adhere to dosing instructions for alendronate in regard to fasting and positioning • Not ambulatory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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 participants bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. Measure:Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD) Timepoints:Baseline and Month 12 ; Outcome name: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. Measure:Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once Timepoints:Baseline through Month 12 ; Outcome name: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). Measure:Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once Timepoints:Baseline through Month 12 ; Outcome name:Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefin | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participants bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. Measure:Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD, Femoral Neck Areal BMD, Trochanter Areal BMD, Total Body Areal BMD, 1/3 Distal Forearm Areal BMD Timepoints:Baseline and Month 12 ; Outcome name:vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. Measure:Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine, Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip, Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine, Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip Timepoints:Baseline and Month 12 ; Outcome name:Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine. C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml). s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml. Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L. Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter Measure:Least Squares Mean Percent Chang | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed