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Completed

NCT Number: NCT00885170

A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has been postmenopausal for at least 5 years
  • Has taken or is taking alendronate
  • Agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion criteria

  • Has a history or evidence of hip fracture
  • Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
  • Has active parathyroid disease
  • Has a history of thyroid disease not adequately controlled by medication
  • Is taking anti-seizure medication and has abnormal calcium metabolism
  • Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening

Treatment and study plan

odanacatib

Drug

Odanacatib 50 mg tablets once weekly for 24 months

Placebo

Drug

Placebo to odanacatib 50 mg tablets once weekly for 24 months

Vitamin D3

Dietary Supplement

Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months

Calcium

Dietary Supplement

Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Primary outcomes

  1. Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24

    Time frame: Baseline and Month 24

    BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.

  2. Percentage of Participants Experiencing One or More Adverse Events (AEs)

    Time frame: Up to 25 months

    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

  3. Percentage of Participants Discontinuing Study Drug Due to an AE

    Time frame: Up to 24 months

    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

Secondary outcomes

  1. Percent Change From Baseline in Femoral Neck BMD at Month 12

    Time frame: Baseline and 12 Months

    BMD at the femoral neck was assessed by DXA at baseline and Month 12.

  2. Percent Change From Baseline in Trochanter BMD at Month 24

    Time frame: Baseline and 24 Months

    BMD at the trochanter was assessed by DXA at baseline and Month 24.

  3. Percent Change From Baseline in Trochanter BMD at Month 12

    Time frame: Baseline and 12 Months

    BMD at the trochanter was assessed by DXA at baseline and Month 12.

  4. Percent Change From Baseline in Total Hip BMD at Month 24

    Time frame: Baseline and 24 Months

    BMD at the total hip was assessed by DXA at baseline and Month 24.

  5. Percent Change From Baseline in Total Hip BMD at Month 12

    Time frame: Baseline and 12 Months

    BMD at the total hip was assessed by DXA at baseline and Month 12.

  6. Percent Change From Baseline in Lumbar Spine BMD at Month 24

    Time frame: Baseline and 24 Months

    BMD at the lumbar spine was assessed by DXA at baseline and Month 24.

  7. Percent Change From Baseline in Lumbar Spine BMD at Month 12

    Time frame: Baseline and 12 Months

    BMD at the lumbar spine was assessed by DXA at baseline and Month 12.

  8. Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24

    Time frame: Baseline and 24 Months

    BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.

  9. Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12

    Time frame: Baseline and 12 Months

    BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.

  10. Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24

    Time frame: Baseline and Month 24

    s-CTx is a biochemical marker of bone resorption.

  11. Percent Change From Baseline in Log-Transformed s-CTx at Month 12

    Time frame: Baseline and Month 12

    s-CTx is a biochemical marker of bone resorption.

  12. Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24

    Time frame: Baseline and Month 24

    N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.

  13. Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12

    Time frame: Baseline and Month 12

    u-NTx/Cr is a biochemical marker of bone resorption.

  14. Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24

    Time frame: Baseline and Month 24

    Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.

  15. Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12

    Time frame: Baseline and Month 12

    BSAP is a biochemical marker of bone formation.

  16. Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24

    Time frame: Baseline and Month 24

    Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.

  17. Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12

    Time frame: Baseline and Month 12

    s-P1NP is a biochemical marker of bone formation.

  18. Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24

    Time frame: Baseline and Month 24

    Serum calcium is an index of calcium homeostasis.

  19. Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24

    Time frame: Baseline and Month 24

    Serum phosphate is an index of mineral homeostasis.

  20. Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24

    Time frame: Baseline and Month 24

    Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.

  21. Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24

    Time frame: Baseline and Month 24

    1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.

  22. Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24

    Time frame: Baseline and Month 24

    The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 21, 2009
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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