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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2006-004177-95-DK
Date of registration:	18/09/2006
Prospective Registration:	Yes
Primary sponsor:	Novartis Pharma Services AG
Public title:	A single center, randomized, partially blind, placebo controlled, crossover, single oral dose study to assess the effect of concomitant antacid (calcium carbonate) on the pharmacokinetics and pharmacodynamics of SMC021 (0.8 mg salmon calcitonin/200 mg 5-CNAC) in healthy postmenopausal women
Scientific title:	A single center, randomized, partially blind, placebo controlled, crossover, single oral dose study to assess the effect of concomitant antacid (calcium carbonate) on the pharmacokinetics and pharmacodynamics of SMC021 (0.8 mg salmon calcitonin/200 mg 5-CNAC) in healthy postmenopausal women
Date of first enrolment:	19/10/2006
Target sample size:	38
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004177-95
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Denmark

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria:
Female volunteers between the ages of 40 and 70 years with a weight at least 50 kg and a BMI of 18-30, at least 5 years after natural menopause or 6 months after surgical menopause. Menopause will be confirmed by plasma FSH level of >40IU/L.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects meeting any of the following criteria will be excluded from entry into or continuation in the study unless sponsor approval is obtained:
1. Smokers who report cigarette use of = 5 cigarette per day. Smoking will not be allowed on the days of each dosing up to the last blood sampling or the last assessment.
2. Use of any prescription drugs or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening. All concomitant medication must be taken at a stable dose throughout the study. Paracetamol is acceptable as on/off treatment, but must be documented in the Concomitant medications/Significant non-drug therapies page of the CRF.
3. Participation in any clinical investigation within 4 weeks prior to dosing, or less than 10 times the corresponding half life of the drug taken, whichever is longer, or longer if required by local regulations, and for any other limitation of participation based on local regulations.

Age minimum:
Age maximum:
Gender:
Female: yes
Male:

Health Condition(s) or Problem(s) studied

Osteoporosis, osteoarthritis
MedDRA version: 8.1 Level: LLT Classification code 10031282 Term: Osteoporosis

Intervention(s)

Product Name: oral calcitonin
Product Code: SMC021
Pharmaceutical Form: Tablet
INN or Proposed INN: Calcitonin
Other descriptive name: salmon calcitonin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.8-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Balancid Novum
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: calcium carbonate
CAS Number: 471341
Other descriptive name: CALCIUM CARBONATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 449-
INN or Proposed INN: magnesium hydroxide
Other descriptive name: magnesium hydroxide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 104-

Primary Outcome(s)

Primary end point(s): To determine the effect of concomitant antacid (calcium carbonate / magnesium
hydroxide) on the pharmacokinetics and pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5-CNAC)

Secondary Objective: To assess the tolerability of concomitantly-administered antacid and SMC021

Main Objective: To determine the effect of calcium carbonate / magnesium hydroxide on the pharmacokinetics and
pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5-
CNAC)

Secondary Outcome(s)

Secondary ID(s)

CSMC021C2208

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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