Alkem

Date of Assessment *

Subject Initials *

Age (Completed years) *

Height (in cm) *

Weight (in Kg) *

Female patients with confirmed case of postmenopausal osteoporosis? *

Yes No

Clinical Signs and Symptoms*

Clinical Diagnosis *

Duration of current illness*

Age at Menopause (in years)*

History of Previous Fragility Fractures *

Yes No

History of Falls in the Past 12 Months *

Yes No

History of Calcium or Vitamin D Deficiency *

Yes No

Previous medications used for current illness (if any):

Medications being used for other concomitant diseases

Concomitant Disease	Medication	Dose	Frequency	Indication

Treatment prescribed *

Teriparatide Denosumab Both combination

Other medications prescribed for T/t

	Brand Name	Marketing Company Name	Dose	Frequency
Teriparatide
Denosumab

Total Duration of therapy (days) *

Other medications/analgesics prescribed for T/t:

Medication	Dose	Frequency	Duration

	Before Therapy	After Therapy
10-point NRS score for Pain Intensity
Bone Mineral Density (BMD) values (g/cm²)	Lumbar Spine (L1-L4)	Lumbar Spine (L1-L4)
	Femoral Neck	Femoral Neck
	Total Hip	Total Hip

Any new fragility fractures reported during therapy *

Yes No

Mobility status *

Improved No change Worsened

Has a fall risk assessment been documented? *

Yes No

current fall risk level*

Low Moderate High

Clinical symptoms improved?*

Yes No

Patient compliant with the prescribed therapy*

Yes No

Clinical outcome at the end of Teriparatide and denosumab combination therapy*

Resolution Improvement No Change Worsening

Need of additional rescue medications (if any)

Adverse events noted due to study medication *

Yes No

If yes, add details
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Date of resolution (DD/MM/YYYY)	Severity	Action Taken (Specify)	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1						Yes No			Yes No
2						Yes No			Yes No
3						Yes No			Yes No
4						Yes No			Yes No
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If 'Treatment given 'is ticked as 'Yes' then relevant information should be captured on Prior and concomitant Medication Form. † Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

Teriparatide and denosumab

ASSESSMENT 1 - THERAPY EVALUATION

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE ANDMEDICATION

TREATMENT OF CURRENT MEDICAL ILLNESS

CLINICAL RESPONSE

ADVERSE EVENTS