NCT00157690

Brief Summary

The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The investigators hypothesize that in adult CF patients with osteopenia or osteoporosis, alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD that is greater than that observed with placebo at 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2003

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

October 23, 2008

Status Verified

October 1, 2008

Enrollment Period

2.7 years

First QC Date

September 8, 2005

Last Update Submit

October 22, 2008

Conditions

Cystic FibrosisOsteoporosisBone Diseases, Metabolic

Keywords

AlendronateBisphosphonatesCystic FibrosisOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • To determine efficacy of 70 mg alendronate once weekly compared to placebo, measured by changes in LS BMD in adult CF patients after one year of treatment

    12 months

Secondary Outcomes (5)

  • To determine the efficacy of 70 mg alendronate once weekly compared to placebo measured by percent changes in total hip BMD, proximal femur BMD, and N-telopeptide at one year in adult CF patients.

    12 months

  • To determine health-related quality of life (HRQL) using the SF-36 instrument.

    12 months

  • To determine HRQL using the Cystic Fibrosis Questionnaire (CFQ).

    12 months

  • To determine the safety of 70 mg of alendronate given once weekly compared with placebo in adult CF patients

    12 months

  • To determine correlations between BMD and patient characteristics, including but not limited to the following: corticosteroid use, height, weight, body mass index BMI) and forced expired volume in 1 minute (FEV1).

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Alendronate

Drug: Alendronate

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AlendronateDRUG

70 mg 1x weekly for 12 months

Also known as: Fosamax
1
PlaceboDRUG

70 mg 1 x weekly for 12 months

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CF; confirmed by a positive sweat test or DNA analysis
  • age 18 years or above at the time of informed consent
  • osteopenia (-2.5\< BMD t-score\<1.0) or osteoporosis (BMD t-score \<-2.5)t-score at the LS (1-4)or total hip
  • provision of informed consent

You may not qualify if:

  • endoscopy-proven esophagitis, gastritis, ulceration, or abnormalities of the esophagus which delay esophageal emptying such as stricture, achalasia, or esophageal varices
  • significantly impaired renal function; this is defined as serum creatinine \>177 umol/L
  • current or recent (within 1 year prior to randomization) consumption of an excess of alcohol or abuse of drugs; an excess of alcohol is defined as more than four of any of the following per day, or a combination of more that four of the following per day: 30 mL distilled spirits, 240 mL beer, or 120 mL wine
  • history of prior organ transplantation
  • any condition which may interfere with the evaluation of LS BMD as determined in a screening radiograph by a radiologist at the central facility e.g. spinal fusion, confluent aortic calcifications, surgical artefact, excessive osteophytes, or other permanent artefact; hip prostheses or any other condition that may interfere with the evaluation of hip BMD
  • participation in another clinical trial 30 days prior to enrolment or within 6 half-lives of the study drug if applicable
  • pregnancy, lactation, or a desire to become pregnant; safe effective birthcontrol must be used
  • know hypersensitivity or abnormal reaction to study drug or other bisphosphonates
  • use of drugs know to affect bone within 6 months of starting trial medication (e.g. thiazide, diuretics, calcitonin, calcitriol, anabolic steroids, estrogen or estrogen-related drugs (e.g. tamoxifen, raloxifene, tibolone high dose vaginal estrogen), progesterone, fluoride: this does not include the birth control pill
  • use of systemic corticosteroids at a dose of at least 7.5 mg/day or greater within last 6 months
  • concomitant use of any investigational drug other than the study medication
  • current or recent (within 1 year prior to randomization) metabolic bone disorders other than secondary osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia (25-OHD\<25nmol/L), hypoparathyroidism, hyperparathyroidism; TSH outside normal laboratory range, with values that are assessed as clinically significant by the investigator; if on replacement therapy, dose should be stable and TSH within normal range for a minimum of 6 weeks prior to trial enrolment
  • hypocalcemia from any cause, corrected for low albumin
  • any history of cancer; for relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma and patients with a history of successfully treated cervical carcinoma in istu, a documented six-month remission is required before study entry
  • poor medical or psychiatric risk for treatment with an investigational drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dr. Harvey Rabin - Health Sciences Centre

Calgary, Alberta, T2N 4N1, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Centre de Recherche - CHUM

Montreal, Quebec, H2W 1T7, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

CHUL Hospital

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Related Publications (3)

  • Aris RM, Lester GE, Caminiti M, Blackwood AD, Hensler M, Lark RK, Hecker TM, Renner JB, Guillen U, Brown SA, Neuringer IP, Chalermskulrat W, Ontjes DA. Efficacy of alendronate in adults with cystic fibrosis with low bone density. Am J Respir Crit Care Med. 2004 Jan 1;169(1):77-82. doi: 10.1164/rccm.200307-1049OC. Epub 2003 Oct 16.

    PMID: 14563654BACKGROUND

  • Aris RM, Merkel PA, Bachrach LK, Borowitz DS, Boyle MP, Elkin SL, Guise TA, Hardin DS, Haworth CS, Holick MF, Joseph PM, O'Brien K, Tullis E, Watts NB, White TB. Guide to bone health and disease in cystic fibrosis. J Clin Endocrinol Metab. 2005 Mar;90(3):1888-96. doi: 10.1210/jc.2004-1629. Epub 2004 Dec 21.

    PMID: 15613415BACKGROUND

  • Papaioannou A, Kennedy CC, Freitag A, Ioannidis G, O'Neill J, Webber C, Pui M, Berthiaume Y, Rabin HR, Paterson N, Jeanneret A, Matouk E, Villeneuve J, Nixon M, Adachi JD. Alendronate once weekly for the prevention and treatment of bone loss in Canadian adult cystic fibrosis patients (CFOS trial). Chest. 2008 Oct;134(4):794-800. doi: 10.1378/chest.08-0608. Epub 2008 Jul 18.

    PMID: 18641106DERIVED

MeSH Terms

Conditions

Cystic FibrosisOsteoporosisBone Diseases, Metabolic

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Alexandra Papaioannou, M.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Andreas Freitag, M.D.

    McMaster University

    STUDY CHAIR

  • Jonathan D Adachi, M.D.

    McMaster University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

October 23, 2008

Record last verified: 2008-10

Locations

CA(6)