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Completed

NCT Number: NCT00261950

Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Antwerp, Belgium

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About this study

Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (PTH) levels . Patients with secondary HPT may have bone disease (osteodystrophy). Cinacalcet has been used to decrease PTH levels in patients with secondary HPT. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects will be eligible for the study if they meet all of the following criteria:

  • One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be >/= 300 pg/mL.
  • One serum calcium determination obtained from the central laboratory must be >/= 8.4 mg/dL (2.1 mmol/L).
  • One Bone Alkaline Phosphatase (BALP) determination obtained from the central laboratory must be >/= 20.9 ng/mL.
  • Positive histologic confirmation of high bone turnover disease as assessed by the central bone histology center.
  • Treated with dialysis >/= 1 month before the date of informed consent.

Exclusion criteria

Subjects will be ineligible for the study if they:

  • Have an unstable medical condition in the judgment of the investigator.
  • Are pregnant or nursing women.
  • Had a parathyroidectomy in the 3 months before the date of informed consent.
  • For subjects prescribed vitamin D, have received vitamin D therapy for less than 30 days before day 1 or required a change in vitamin D brand or dose level within 30 days before day 1.
  • Ever received therapy with Sensipar®/Mimpara®

Treatment and study plan

Sensipar (Cinacalcet HCl)

Drug

All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.

Primary outcomes

  1. Change From Baseline to End of Study in Bone Formation Rate (BFR)

    Time frame: Baseline to week 52

Secondary outcomes

  1. Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)

    Time frame: Baseline to weeks 40-52

  2. Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)

    Time frame: Baseline to weeks 40-52

  3. Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)

    Time frame: Baseline to weeks 40-52

  4. Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52

    Time frame: Baseline to week 52

  5. Percent Change From Baseline in N - Telopeptide (NTx) at Week 52

    Time frame: Baseline to week 52

  6. Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)

    Time frame: Baseline to weeks 40-52

  7. Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)

    Time frame: Baseline to week 52

    Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100"

  8. Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)

    Time frame: Baseline to week 52

    Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100"

  9. Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area

    Time frame: Baseline to week 52

    Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)

  10. Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter

    Time frame: Baseline to week 52

    Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100"

  11. Percent Change From Baseline in Osteocalcin (OC) at Week 52

    Time frame: Baseline to week 52

  12. Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52

    Time frame: Baseline to week 52

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

Acronym: BONAFIDE

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2005
Registry last updated
Jul 21, 2014

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

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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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