Trial Outcomes & Findings for Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM) (NCT NCT00479037)

Last Updated: 2012-05-08

Results Overview

P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen. Bone marker measurements were done by blood analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

82 participants

Primary outcome timeframe

Baseline and 24 weeks of treatment

Results posted on

2012-05-08

Participant Flow

82 subjects were randomized. Of these, one subject was randomized, but consent was withdrawn during the screening period; the subject did not receive any treatment. Therefore, the Intention to treat set (ITT) consisted of 81 subjects.

Participant milestones

Participant milestones
Measure	PTH(1-84) Once daily subcutaneous injection	Strontium Ranelate One sachet (2 g) per day, suspended in water
Overall Study STARTED	41	40
Overall Study COMPLETED	38	34
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTH(1-84) n=41 Participants Once daily subcutaneous injection	Strontium Ranelate n=40 Participants One sachet (2 g) per day, suspended in water	Total n=81 Participants Total of all reporting groups
Age Continuous	64.0 years STANDARD_DEVIATION 8.64 • n=5 Participants	64.9 years STANDARD_DEVIATION 8.49 • n=7 Participants	64.4 years STANDARD_DEVIATION 8.52 • n=5 Participants
Sex/Gender, Customized Female	41 participants n=5 Participants	40 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks of treatment

Population: ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.

Outcome measures

Outcome measures
Measure	Strontium Ranelate n=40 Participants One sachet (2 g) per day, suspended in water	PTH(1-84) n=41 Participants Once daily subcutaneous injection
Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial	-6.2 percent change Standard Deviation 36.9	446.1 percent change Standard Deviation 355.3

PRIMARY outcome

Timeframe: Baseline and 24 weeks of treatment

Population: ITT analysis. Number of participants analyzed = number of participants with data available.

BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts. Bone marker measurements were done by blood analysis.

Outcome measures

Outcome measures
Measure	Strontium Ranelate n=40 Participants One sachet (2 g) per day, suspended in water	PTH(1-84) n=41 Participants Once daily subcutaneous injection
Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial	4.9 percent change Standard Deviation 22.9	129.6 percent change Standard Deviation 100.3

SECONDARY outcome

Timeframe: Baseline and 24 weeks of treatment

Population: ITT analysis. Number of participants analyzed = number of participants with data available.

CTX is a marker of bone resorption, which is a degradation product of bone collagen. Bone marker measurements were done by blood analysis.

Outcome measures

Outcome measures
Measure	Strontium Ranelate n=40 Participants One sachet (2 g) per day, suspended in water	PTH(1-84) n=41 Participants Once daily subcutaneous injection
Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial	-3.7 percent change Standard Deviation 36.0	153.3 percent change Standard Deviation 132.4

Adverse Events

PTH(1-84)

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Strontium Ranelate

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PTH(1-84) n=40 participants at risk Once daily subcutaneous injection	Strontium Ranelate n=40 participants at risk One sachet (2 g) per day, suspended in water
Endocrine disorders Goitre	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Infections and infestations Urinary Tract Infection	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Nervous system disorders Syncope	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Vascular disorders Hypertensive Crisis	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug

Other adverse events

Additional Information

Clinical Trial Operations

Nycomed

Phone: +45 4677 1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After publication of the results or 24 months after Clinical Trial Report has been finalised, whichever comes first, Nycomed acknowledge the Investigator's rights to publish results from this trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted to Nycomed prior to submission for publication/presentation for review. Review comments will be given within a month from receipt of the manuscript.
Publication restrictions are in place

Restriction type: OTHER

Measure	PTH(1-84) n=40 participants at risk Once daily subcutaneous injection	Strontium Ranelate n=40 participants at risk One sachet (2 g) per day, suspended in water
Gastrointestinal disorders Nausea, mild severity	12.5% 5/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Gastrointestinal disorders Nausea, moderate severity	7.5% 3/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	7.5% 3/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Gastrointestinal disorders Abdominal pain upper	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Gastrointestinal disorders Diarrhoea	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Metabolism and nutrition disorders Hypercalcaemia / mild severity	20.0% 8/40 • Number of events 9 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Metabolism and nutrition disorders Hypercalcaemia / moderate severity	7.5% 3/40 • Number of events 3 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Metabolism and nutrition disorders Hypervitaminosis D	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Nervous system disorders Headache, mild severity	7.5% 3/40 • Number of events 3 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Nervous system disorders Headache, moderate severity	15.0% 6/40 • Number of events 7 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 2/40 • Number of events 3 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Infections and infestations Tooth infection	2.5% 1/40 • Number of events 1 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
General disorders Malaise	7.5% 3/40 • Number of events 3 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
General disorders Chills	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Vascular disorders Hypertension	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Vascular disorders Venous insufficiency	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Psychiatric disorders Insomnia	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
Ear and labyrinth disorders Vertigo	5.0% 2/40 • Number of events 2 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug	0.00% 0/40 All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug